Preterm DeliveryNCT07491874
Use of Nitrous Oxide for Pain and Anxiety Management During Cervical Cerclage Removal
A study testing Inhaled nitrous oxide in people with Preterm Delivery and Cervical Cerclage, run by Kaplan Medical Center at 4 sites in Israel.
Trial summary
The goal of this clinical trial is to determine whether inhaled nitrous oxide can reduce pain and anxiety during cervical cerclage removal compared with standard care. Cervical cerclage removal is commonly performed in the outpatient setting during the third trimester of pregnancy and may be associated with discomfort… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Preterm Delivery, Cervical Cerclage, Cervical Insufficiency
- What is being tested?
- Inhaled nitrous oxide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesIsrael
- Study dates
- 1 May 2026to 1 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥18 years
- Women at ≥34 weeks of gestation
- Singleton or twin pregnancy
- Ability to understand, sign informed consent, and complete questionnaires
Who cannot join
- Triplet or higher-order pregnancy
- Contraindications to nitrous oxide use
- Fetal monitoring category 2 or higher
- Maternal body temperature >38°C
- Significant vaginal bleeding
- Severe preeclampsia
Show all 9Show fewer
- Cerclage removal under general anesthesia
- Language or cognitive barrier
- Baseline pain >3 on VAS scale, prior to the procedure
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Israel4 sites
Edith Wolfson Medical Center
Holon
Liat Mor, +972546738294, liatmor1@gmail.com
Meir Medical Center
Kfar Saba
Sapir Nachshon, +972526525154, Sapir4790@gmail.com
Rabin Medical Center
Petah Tikva
Bar Narkis, +972546335114
Kaplan Medical Center
Rehovot, Central District, 7639302
Gil Friedman, +972584744356, gilfriedman51@gmail.com
About this study
Official title: Use of Nitrous Oxide for Pain and Anxiety Management During Cervical Cerclage Removal- A Multicenter Randomized Controlled Study
The goal of this clinical trial is to determine whether inhaled nitrous oxide can reduce pain and anxiety during cervical cerclage removal compared with standard care. Cervical cerclage removal is commonly performed in the outpatient setting during the third trimester of pregnancy and may be associated with discomfort and anxiety despite being a brief procedure.
The study will include pregnant women aged 18 years or older undergoing elective cervical cerclage removal at 36 weeks of gestation or later.
Read more
The main questions the study aims to answer are:
- Does inhaled nitrous oxide reduce pain during cervical cerclage removal?
- Does inhaled nitrous oxide reduce anxiety during the procedure?
- Does the use of nitrous oxide improve overall patient satisfaction during cerclage removal?
Researchers will compare women receiving inhaled nitrous oxide to those receiving standard care without analgesia, as routinely practiced in the participating institutions, in order to determine whether nitrous oxide improves pain control and patient experience during the procedure.
Participants will:
- Be randomly assigned to receive either inhaled nitrous oxide (50% nitrous oxide / 50% oxygen) or standard care without analgesic treatment during cervical cerclage removal.
- Undergo the procedure according to routine clinical practice in the participating centers.
- Complete questionnaires assessing pain and anxiety, including a visual analog scale (VAS) for pain and the State-Trait Anxiety Inventory (STAI).
- Have routine clinical data recorded from their medical records, including maternal vital signs and any procedure-related side effects.
Read the detailed description
Cervical insufficiency is a recognized risk factor for spontaneous preterm birth, which remains a major cause of perinatal morbidity and mortality worldwide. Cervical cerclage is an established intervention used in carefully selected patients to reduce the risk of preterm birth.
While cerclage placement is typically performed under anesthesia in the operating room, cerclage removal is usually carried out in the outpatient setting during the late third trimester of pregnancy. Despite being a brief procedure, many patients experience pain, discomfort, and anxiety during cerclage removal. Evidence regarding optimal pain management strategies for this procedure remains limited, and most patients currently undergo cerclage removal without analgesia.
Nitrous oxide (N₂O) is an inhaled gas with well-established analgesic and anxiolytic properties. It has a rapid onset and offset of action and a favorable safety profile. Nitrous oxide is widely used in obstetrics, particularly for labor analgesia, and has also been used for pain management during minor medical procedures. However, its use specifically for cervical cerclage removal has not been well studied.
This study is a multicenter randomized controlled trial designed to evaluate whether inhaled nitrous oxide reduces pain and anxiety during elective cervical cerclage removal. Participants will be randomly assigned in a 1:1 ratio to receive either inhaled nitrous oxide (50% nitrous oxide / 50% oxygen) during the procedure or standard care without analgesic treatment, as routinely practiced in the participating institutions. Randomization will be stratified by site and implemented using sequentially numbered sealed envelopes opened immediately prior to the procedure.
All procedures will be performed according to routine clinical practice in the participating centers. Maternal and procedural data will be collected from medical records, including procedure duration, maternal vital signs, and any reported side effects such as nausea, dizziness, or headache. Pain intensity will be assessed using a 0-100 mm visual analog scale (VAS), and anxiety levels will be evaluated using the State-Trait Anxiety Inventory (STAI). Additional outcomes will include maternal heart rate during the procedure and patient satisfaction with the procedure.
This trial aims to determine whether inhaled nitrous oxide can effectively reduce pain and anxiety during cervical cerclage removal. The findings of this study may provide evidence to support improved pain management strategies for this procedure and may contribute to enhancing patient experience during cerclage removal.
- Conditions
- Preterm Delivery, Cervical Cerclage, Cervical Insufficiency
- Being tested
- Inhaled nitrous oxide
- Medical subject headings
- Premature Birth, Uterine Cervical Incompetence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inhaled nitrous oxideDrug
Also called N2O
Inhaled nitrous oxide (50% nitrous oxide / 50% oxygen) administered via a demand-valve mask during cervical cerclage removal. The system includes a one-way valve and is self-administered by the patient, who holds the mask and inhales as needed. The device is identical to the equipment routinely used for labor analgesia in the participating institutions and is operated and monitored by trained midwives experienced in nitrous oxide administration.
Nitrous oxide inhalation begins following instruction from the performing physician. The procedure starts approximately three minutes after inhalation begins, once adequate analgesia and anxiolysis are achieved. Continuous pulse oximetry monitoring is performed during administration. After completion of the procedure, nitrous oxide is discontinued and the patient breathes room air.
| Study group | Role | What they receive |
|---|---|---|
| Inhaled Nitrous Oxide During Cervical Cerclage Removal | Experimental | Participants in this arm will receive inhaled nitrous oxide (50% nitrous oxide / 50% oxygen) administered via a demand-valve mask during cervical cerclage removal. The system includes a one-way valve and is self-administered by the patient, who holds the mask and inhales as needed. The equipment is identical to the device routinely used for labor analgesia in the participating institutions and will be operated and monitored by trained midwives experienced in nitrous oxide administration.
Continuous pulse oximetry monitoring will be initiated prior to gas administration. Nitrous oxide inhalation will begin following instruction from the performing physician, and the procedure will start approximately three minutes after inhalation begins once adequate analgesia and anxiolysis are achieved. After completion of the procedure, nitrous oxide will be discontinued and the patient will breathe room air. The patient will remain in bed for approximately 15 minutes with fetal monitoring to conf Receives: Drug: Inhaled nitrous oxide |
| Standard Care Without Analgesia | No intervention | Participants in this arm will undergo cervical cerclage removal without analgesia, in accordance with the standard practice across the participating institutions. The procedure will be performed in the outpatient setting following routine clinical protocols. Maternal vital signs and fetal status will be monitored according to standard clinical practice. No nitrous oxide or other analgesic intervention will be administered as part of the study protocol. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity during cervical cerclage removal
Pain intensity will be assessed using a 0-100 mm visual analog scale (VAS). Participants will rate the level of pain experienced during the procedure 3-5 minutes after completion of the cerclage removal.
Measured: 3-5 minutes following completion of the procedure
Secondary outcomes (8)
Difference between expected pain and experienced pain
Expected and experienced pain will be assessed using a 0-100 mm Visual Analog Scale (VAS), where higher scores indicate greater pain intensity. The difference between expected and experienced pain scores will be calculated.
Measured: Baseline (prior to procedure) and 3-5 minutes following completion of the procedure
Procedure duration
Total duration of the cerclage removal procedure, measured in minutes from the beginning of the procedure to completion.
Measured: During procedure
Change in maternal heart rate during procedure
Difference (delta) between baseline maternal heart rate and the maximal heart rate recorded during the procedure
Measured: Baseline measurement prior to the procedure and continuous monitoring during the procedure
Change in anxiety level (STAI)
Anxiety levels will be assessed using the State-Trait Anxiety Inventory (STAI). The STAI score ranges from 20 to 80, with higher scores indicating higher levels of anxiety. Participants will complete the questionnaire before the procedure and again after cerclage removal. The change in STAI score will be analyzed.
Measured: Baseline (before procedure) and 3-5 minutes after completion of the procedure
Patient satisfaction
Patient satisfaction will be assessed using a 5-point Likert scale, where 1 indicates very low satisfaction and 5 indicates very high satisfaction. The questionnaire will be completed after cerclage removal.
Measured: 3-5 minutes after completion of the procedure
Adverse events
Occurrence of adverse events including nausea, dizziness, headache, or dyspnea reported during or immediately after the procedure
Measured: During procedure
Conversion to neuraxial or general anesthesia
Need to convert from the assigned study condition (nitrous oxide or no analgesia) to epidural, spinal, or general anesthesia due to inability to complete the procedure
Measured: During the procedure
Physician-rated procedural difficulty
The performing physician will provide a subjective assessment of the technical difficulty of cervical cerclage removal. Procedural difficulty will be assessed using a 5-point Likert scale, where 1 indicates very easy and 5 indicates very difficult.
Measured: 3-5 minutes following completion of the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- Other trials for Preterm DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaplan Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Clalit Health Services, Wolfson Medical Center, Rabin Medical Center, Meir Medical Center
- Responsible party
- Principal investigator, Gil Friedman, Kaplan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491874
- Sponsor's protocol ID
- 0034-26-KMC1-C
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Teichman Y. and Mellik H. (1976). "State-Trait Anxiety Inventory," Tel-Aviv University, Ramot Press
American College of Emergency Physicians. Managing Acute Pain in the ED - Nitrous Oxide. ACEP // Nitrous Oxide (viewed July 2021)
Spielberger, C., Gorsuch, R., & Lushene, R. (1970). Manual for the State-Trait Anxiety Inventory
Rosen MA. Nitrous oxide for relief of labor pain: a systematic review. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S110-26. doi: 10.1067/mob.2002.121259.
PubMed 12011877Del Valle Rubido C, Solano Calvo JA, Rodriguez Miguel A, Delgado Espeja JJ, Gonzalez Hinojosa J, Zapico Goni A. Inhalation analgesia with nitrous oxide versus other analgesic techniques in hysteroscopic polypectomy: a pilot study. J Minim Invasive Gynecol. 2015 May-Jun;22(4):595-600. doi: 10.1016/j.jmig.2015.01.005. Epub 2015 Jan 14.
PubMed 25596171Stewart RD. Nitrous oxide sedation/analgesia in emergency medicine. Ann Emerg Med. 1985 Feb;14(2):139-48. doi: 10.1016/s0196-0644(85)81077-5.
PubMed 4038592Veger ML, van Iterson J, Bakx R, Ridderikhof ML. The Role of Nitrous Oxide in Minor Pediatric Procedures in the Emergency Department: A Systematic Review. J Pediatr Surg. 2024 Jun;59(6):1154-1162. doi: 10.1016/j.jpedsurg.2023.12.026. Epub 2024 Jan 14.
PubMed 38368199Pain Management for In-Office Uterine and Cervical Procedures: ACOG Clinical Consensus No. 9. Obstet Gynecol. 2025 May 15;146(1):161-177. doi: 10.1097/AOG.0000000000005911.
PubMed 40373312Singh RH, Montoya M, Espey E, Leeman L. Nitrous oxide versus oral sedation for pain management of first-trimester surgical abortion - a randomized study. Contraception. 2017 Aug;96(2):118-123. doi: 10.1016/j.contraception.2017.06.003. Epub 2017 Jun 16.
PubMed 28629738Fowler KG, Byraiah G, Burt C, Lee DB, Miller RJ. Nitrous Oxide Use for Intrauterine System Placement in Adolescents. J Pediatr Adolesc Gynecol. 2022 Apr;35(2):159-164. doi: 10.1016/j.jpag.2021.10.019. Epub 2021 Nov 6.
PubMed 34748915Solano Calvo JA, Del Valle Rubido C, Rodriguez-Miguel A, de Abajo FJ, Delgado Espeja JJ, Gonzalez Hinojosa J, Fernandez Munoz L, Zapico Goni A. Nitrous oxide versus lidocaine versus no analgesic for in-office hysteroscopy: a randomised clinical trial. BJOG. 2021 Jul;128(8):1364-1372. doi: 10.1111/1471-0528.16657. Epub 2021 Mar 9.
PubMed 33528862Schneider EN, Riley R, Espey E, Mishra SI, Singh RH. Nitrous oxide for pain management during in-office hysteroscopic sterilization: a randomized controlled trial. Contraception. 2017 Mar;95(3):239-244. doi: 10.1016/j.contraception.2016.09.006. Epub 2016 Sep 9.
PubMed 27621048Giouleka S, Boureka E, Tsakiridis I, Siargkas A, Mamopoulos A, Kalogiannidis I, Athanasiadis A, Dagklis T. Cervical Cerclage: A Comprehensive Review of Major Guidelines. Obstet Gynecol Surv. 2023 Sep;78(9):544-553. doi: 10.1097/OGX.0000000000001182.
PubMed 37976303ACOG Practice Bulletin No.142: Cerclage for the management of cervical insufficiency. Obstet Gynecol. 2014 Feb;123(2 Pt 1):372-379. doi: 10.1097/01.AOG.0000443276.68274.cc.
PubMed 24451674Ioscovich A, Popov A, Gimelfarb Y, Gozal Y, Orbach-Zinger S, Shapiro J, Ginosar Y. Anesthetic management of prophylactic cervical cerclage: a retrospective multicenter cohort study. Arch Gynecol Obstet. 2015 Mar;291(3):509-12. doi: 10.1007/s00404-014-3391-5. Epub 2014 Aug 8.
PubMed 25103960
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Nitrous Oxide for Pain and Anxiety Management During Cervical Cerclage Removal- A Multicenter Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07491874
- Acronym / sponsor ID
- 0034-26-KMC1-C
- Conditions
- Preterm Delivery, Cervical Cerclage, Cervical Insufficiency
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kaplan Medical CenterUniversity, hospital or other
- Collaborators
- Clalit Health Services, Wolfson Medical Center, Rabin Medical Center, Meir Medical Center
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to determine whether inhaled nitrous oxide can reduce pain and anxiety during cervical cerclage removal compared with standard care. Cervical cerclage removal is commonly performed in the outpatient setting during the third trimester of pregnancy and may be associated with discomfort and anxiety despite being a brief procedure.
The study will include pregnant women aged 18 years or older undergoing elective cervical cerclage removal at 36 weeks of gestation or later.
The main questions the study aims to answer are:
- Does inhaled nitrous oxide reduce pain during cervical cerclage removal?
- Does inhaled nitrous oxide reduce anxiety during the procedure?
- Does the use of nitrous oxide improve overall patient satisfaction during cerclage removal?
Researchers will compare women receiving inhaled nitrous oxide to those receiving standard care without analgesia, as routinely practiced in the participating institutions, in order to determine whether nitrous oxide improves pain control and patient experience during the procedure.
Participants will:
- Be randomly assigned to receive either inhaled nitrous oxide (50% nitrous oxide / 50% oxygen) or standard care without analgesic treatment during cervical cerclage removal.
- Undergo the procedure according to routine clinical practice in the participating centers.
- Complete questionnaires assessing pain and anxiety, including a visual analog scale (VAS) for pain and the State-Trait Anxiety Inventory (STAI).
- Have routine clinical data recorded from their medical records, including maternal vital signs and any procedure-related side effects.
Detailed description
Cervical insufficiency is a recognized risk factor for spontaneous preterm birth, which remains a major cause of perinatal morbidity and mortality worldwide. Cervical cerclage is an established intervention used in carefully selected patients to reduce the risk of preterm birth.
While cerclage placement is typically performed under anesthesia in the operating room, cerclage removal is usually carried out in the outpatient setting during the late third trimester of pregnancy. Despite being a brief procedure, many patients experience pain, discomfort, and anxiety during cerclage removal. Evidence regarding optimal pain management strategies for this procedure remains limited, and most patients currently undergo cerclage removal without analgesia.
Nitrous oxide (N₂O) is an inhaled gas with well-established analgesic and anxiolytic properties. It has a rapid onset and offset of action and a favorable safety profile. Nitrous oxide is widely used in obstetrics, particularly for labor analgesia, and has also been used for pain management during minor medical procedures. However, its use specifically for cervical cerclage removal has not been well studied.
This study is a multicenter randomized controlled trial designed to evaluate whether inhaled nitrous oxide reduces pain and anxiety during elective cervical cerclage removal. Participants will be randomly assigned in a 1:1 ratio to receive either inhaled nitrous oxide (50% nitrous oxide / 50% oxygen) during the procedure or standard care without analgesic treatment, as routinely practiced in the participating institutions. Randomization will be stratified by site and implemented using sequentially numbered sealed envelopes opened immediately prior to the procedure.
All procedures will be performed according to routine clinical practice in the participating centers. Maternal and procedural data will be collected from medical records, including procedure duration, maternal vital signs, and any reported side effects such as nausea, dizziness, or headache. Pain intensity will be assessed using a 0-100 mm visual analog scale (VAS), and anxiety levels will be evaluated using the State-Trait Anxiety Inventory (STAI). Additional outcomes will include maternal heart rate during the procedure and patient satisfaction with the procedure.
This trial aims to determine whether inhaled nitrous oxide can effectively reduce pain and anxiety during cervical cerclage removal. The findings of this study may provide evidence to support improved pain management strategies for this procedure and may contribute to enhancing patient experience during cerclage removal.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inhaled Nitrous Oxide During Cervical Cerclage Removal | Experimental | Drug: Inhaled nitrous oxideParticipants in this arm will receive inhaled nitrous oxide (50% nitrous oxide / 50% oxygen) administered via a demand-valve mask during cervical cerclage removal. The system includes a one-way valve and is self-administered by the patient, who holds the mask and inhales as needed. The equipment is identical to the device routinely used for labor analgesia in the participating institutions and will be operated and monitored by trained midwives experienced in nitrous oxide administration. Continuous pulse oximetry monitoring will be initiated prior to gas administration. Nitrous oxide inhalation will begin following instruction from the performing physician, and the procedure will start approximately three minutes after inhalation begins once adequate analgesia and anxiolysis are achieved. After completion of the procedure, nitrous oxide will be discontinued and the patient will breathe room air. The patient will remain in bed for approximately 15 minutes with fetal monitoring to conf |
| Standard Care Without Analgesia | No intervention | –Participants in this arm will undergo cervical cerclage removal without analgesia, in accordance with the standard practice across the participating institutions. The procedure will be performed in the outpatient setting following routine clinical protocols. Maternal vital signs and fetal status will be monitored according to standard clinical practice. No nitrous oxide or other analgesic intervention will be administered as part of the study protocol. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥18 years
- Women at ≥34 weeks of gestation
- Singleton or twin pregnancy
- Ability to understand, sign informed consent, and complete questionnaires
Key exclusion criteria (9 listed)
- Triplet or higher-order pregnancy
- Contraindications to nitrous oxide use
- Fetal monitoring category 2 or higher
- Maternal body temperature >38°C
- Significant vaginal bleeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inhaled nitrous oxideAlso: N2OInhaled nitrous oxide (50% nitrous oxide / 50% oxygen) administered via a demand-valve mask during cervical cerclage removal. The system includes a one-way valve and is self-administered by the patient, who holds the mask and inhales as needed. The device is identical to the equipment routinely used for labor analgesia in the participating institutions and is operated and monitored by trained midwives experienced in nitrous oxide administration. Nitrous oxide inhalation begins following instruction from the performing physician. The procedure starts approximately three minutes after inhalation begins, once adequate analgesia and anxiolysis are achieved. Continuous pulse oximetry monitoring is performed during administration. After completion of the procedure, nitrous oxide is discontinued and the patient breathes room air. | Drug | Inhaled Nitrous Oxide During Cervical Cerclage Removal |
Primary outcome
Pain intensity during cervical cerclage removal
Time frame: 3-5 minutes following completion of the procedure
Pain intensity will be assessed using a 0-100 mm visual analog scale (VAS). Participants will rate the level of pain experienced during the procedure 3-5 minutes after completion of the cerclage removal.
8 secondary outcomes
Difference between expected pain and experienced pain
Time frame: Baseline (prior to procedure) and 3-5 minutes following completion of the procedure
Procedure duration
Time frame: During procedure
Change in maternal heart rate during procedure
Time frame: Baseline measurement prior to the procedure and continuous monitoring during the procedure
Change in anxiety level (STAI)
Time frame: Baseline (before procedure) and 3-5 minutes after completion of the procedure
Patient satisfaction
Time frame: 3-5 minutes after completion of the procedure
Adverse events
Time frame: During procedure
Conversion to neuraxial or general anesthesia
Time frame: During the procedure
Physician-rated procedural difficulty
Time frame: 3-5 minutes following completion of the procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
- BackgroundTeichman Y. and Mellik H. (1976). "State-Trait Anxiety Inventory," Tel-Aviv University, Ramot Press
- BackgroundAmerican College of Emergency Physicians. Managing Acute Pain in the ED - Nitrous Oxide. ACEP // Nitrous Oxide (viewed July 2021)
- BackgroundSpielberger, C., Gorsuch, R., & Lushene, R. (1970). Manual for the State-Trait Anxiety Inventory
- Background: PubMed 12011877Rosen MA. Nitrous oxide for relief of labor pain: a systematic review. Am J Obstet Gynecol. 2002 May;186(5 Suppl Nature):S110-26. doi: 10.1067/mob.2002.121259.
- Background: PubMed 25596171Del Valle Rubido C, Solano Calvo JA, Rodriguez Miguel A, Delgado Espeja JJ, Gonzalez Hinojosa J, Zapico Goni A. Inhalation analgesia with nitrous oxide versus other analgesic techniques in hysteroscopic polypectomy: a pilot study. J Minim Invasive Gynecol. 2015 May-Jun;22(4):595-600. doi: 10.1016/j.jmig.2015.01.005. Epub 2015 Jan 14.
- Background: PubMed 4038592Stewart RD. Nitrous oxide sedation/analgesia in emergency medicine. Ann Emerg Med. 1985 Feb;14(2):139-48. doi: 10.1016/s0196-0644(85)81077-5.
- Background: PubMed 38368199Veger ML, van Iterson J, Bakx R, Ridderikhof ML. The Role of Nitrous Oxide in Minor Pediatric Procedures in the Emergency Department: A Systematic Review. J Pediatr Surg. 2024 Jun;59(6):1154-1162. doi: 10.1016/j.jpedsurg.2023.12.026. Epub 2024 Jan 14.
- Background: PubMed 40373312Pain Management for In-Office Uterine and Cervical Procedures: ACOG Clinical Consensus No. 9. Obstet Gynecol. 2025 May 15;146(1):161-177. doi: 10.1097/AOG.0000000000005911.
- Background: PubMed 28629738Singh RH, Montoya M, Espey E, Leeman L. Nitrous oxide versus oral sedation for pain management of first-trimester surgical abortion - a randomized study. Contraception. 2017 Aug;96(2):118-123. doi: 10.1016/j.contraception.2017.06.003. Epub 2017 Jun 16.
- Background: PubMed 34748915Fowler KG, Byraiah G, Burt C, Lee DB, Miller RJ. Nitrous Oxide Use for Intrauterine System Placement in Adolescents. J Pediatr Adolesc Gynecol. 2022 Apr;35(2):159-164. doi: 10.1016/j.jpag.2021.10.019. Epub 2021 Nov 6.
- Background: PubMed 33528862Solano Calvo JA, Del Valle Rubido C, Rodriguez-Miguel A, de Abajo FJ, Delgado Espeja JJ, Gonzalez Hinojosa J, Fernandez Munoz L, Zapico Goni A. Nitrous oxide versus lidocaine versus no analgesic for in-office hysteroscopy: a randomised clinical trial. BJOG. 2021 Jul;128(8):1364-1372. doi: 10.1111/1471-0528.16657. Epub 2021 Mar 9.
- Background: PubMed 27621048Schneider EN, Riley R, Espey E, Mishra SI, Singh RH. Nitrous oxide for pain management during in-office hysteroscopic sterilization: a randomized controlled trial. Contraception. 2017 Mar;95(3):239-244. doi: 10.1016/j.contraception.2016.09.006. Epub 2016 Sep 9.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inhaled nitrous oxide in people with Preterm Delivery and Cervical Cerclage, run by Kaplan Medical Center at 4 sites in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Gil Friedman (+972584744356, gilfriedman51@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity during cervical cerclage removal (time frame: 3-5 minutes following completion of the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07491874, which also lists 19 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026.