Premature Rupture of Fetal MembranesNIPROMNCT03025581
Does Nipple Stimulation Shorten Time to Vaginal Birth in Women With Term PROM?
A study testing Nipple stimulation in people with Premature Rupture of Fetal Membranes, run by Hillel Yaffe Medical Center at 1 site in Israel.
Trial summary
Premature Rupture of Membranes (PROM) is defined as the rupture of membranes before the onset of regular uterine contractions. PROM occurs in approximately 10% of all pregnancies (ranging from 2.7% to 17%), with 60% to 80% of cases occurring at term. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Premature Rupture of Fetal Membranes
- What is being tested?
- Nipple stimulation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteIsrael
- Study dates
- Jan 2017to Jan 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Primagravidas at term (>37) weeks having PROM
- Singleton pregnancies
- Cephalic presentation
- Unfavorable cervix (Bishop score <7)
- Desire an expectant management
Who cannot join
- Prior cesarean section/ uterine rupture / transmural uterine incision
- Non reassuring fetal heart rate monitoring (Category III)
- Signs of fetal or maternal infection
- Time elapsed since PROM > 6 hours
- Meconium or blood-stained amniotic fluid
- Any contraindication for vaginal birth
Trial locations and contacts
1 site in 1 country.
Ofer Limonad, M.D contact
Esti Maor, M.D contact
Israel1 site
Hillel Yaffe Medical Center
Hadera
Ofer Limonad, M.D, oferlimonad@gmail.com
Esti Maor, M.D, oferlimonad@gmail.com
About this study
Official title: Does Nipple Stimulation Shorten Time to Vaginal Birth in Women With Term PROM? (NIPROM Study)
Premature Rupture of Membranes (PROM) is defined as the rupture of membranes before the onset of regular uterine contractions.
PROM occurs in approximately 10% of all pregnancies (ranging from 2.7% to 17%), with 60% to 80% of cases occurring at term. Approximately 90% of patients' experience PROM enter spontaneous labor within 24 hours, but disagreement exists among health care providers on the optimal management of women with PROM, particularly the need for and timing of inductions.
Read more
Nipple stimulation is a non-medical natural method for induction of labor. Previous studies demonstrated its effectiveness for initiating labor within 72 hours in women with favorable cervices. The actual mechanism by which such a technique results in cervical ripening is not well understood.
In this study, we aim to assess the effectiveness of nipple stimulation in gravid women with term PROM choosing expectant management.
Read the detailed description
The participants in the study will be randomized into two groups of expectant management (patients desire an active approach will be excluded).
All eligible participants will be randomly allocated to either intervention or control group. They will be followed from the time of presentation with rupture of membranes at the ER and until the time of delivery. Prophylactic antibiotics will be administered after 18 hours from rupture of membranes as per departmental policy.
On admission, and after validating inclusion criteria, women will be offered to join the study. For the intervention group women will be instructed to gently massage alternate breasts, especially around the nipples for 15 minutes every 6 hours until the appearance of regular contractions but not more than 24 hours. Moist cloth or lubricating or moisturizing cream will be offered to facilitate the procedure according to individual preferences. In the control group all participants will be asked to avoid any breast stimulation during the study period.
For both groups maternal surveillance will include obstetrician assessment every 6 hours or per maternal request if painful contractions. Every assessment will include documenting maternal vital signs, sense of contraction, fetal cardiotocographic assessment and vaginal examination if painful contractions. After delivery,all participants will be requested to fill a satisfaction questionnaire.
- Conditions
- Premature Rupture of Fetal Membranes
- Being tested
- Nipple stimulation
- Medical subject headings
- Fetal Membranes, Premature Rupture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nipple stimulationOther
For the intervention group participants will be instructed to gently massage alternate breasts, especially around the nipples for 15 minutes every 6 hours until the appearance of regular contractions but not more than 24 hours. Moist cloth or lubricating or moisturizing cream will be offered to facilitate the procedure according to individual preferences. In the control group all participants will be asked to avoid any breast stimulation during the study period.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Active comparator | Nipple stimulation. Receives: Other: Nipple stimulation |
| Control group | No intervention | No intervention (expectant management only). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Premature Rupture of Fetal MembranesStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Mordechai Hallak, M.D, Principal investigator, Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, HaderaRinat Gabbay, M.D, Study director, Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, Hadera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025581
- Sponsor's protocol ID
- 0091-HYMC
- Acronym
- NIPROM
- Status last verified
- Jan 2017
- First submitted
- 6 Jan 2017
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Hannah ME, Ohlsson A, Farine D, Hewson SA, Hodnett ED, Myhr TL, Wang EE, Weston JA, Willan AR. Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group. N Engl J Med. 1996 Apr 18;334(16):1005-10. doi: 10.1056/NEJM199604183341601.
PubMed 8598837Cahill AG, Tuuli MG. Labor in 2013: the new frontier. Am J Obstet Gynecol. 2013 Dec;209(6):531-4. doi: 10.1016/j.ajog.2013.04.016. Epub 2013 Apr 10.
PubMed 23583208Christensson K, Nilsson BA, Stock S, Matthiesen AS, Uvnas-Moberg K. Effect of nipple stimulation on uterine activity and on plasma levels of oxytocin in full term, healthy, pregnant women. Acta Obstet Gynecol Scand. 1989;68(3):205-10. doi: 10.3109/00016348909020990.
PubMed 2618602Elliott JP, Flaherty JF. The use of breast stimulation to ripen the cervix in term pregnancies. Am J Obstet Gynecol. 1983 Mar 1;145(5):553-6. doi: 10.1016/0002-9378(83)91194-8.
PubMed 6338721Elliott JP, Flaherty JF. The use of breast stimulation to prevent postdate pregnancy. Am J Obstet Gynecol. 1984 Jul 15;149(6):628-32. doi: 10.1016/0002-9378(84)90247-3.
PubMed 6377899Hill WC, Moenning RK, Katz M, Kitzmiller JL. Characteristics of uterine activity during the breast stimulation stress test. Obstet Gynecol. 1984 Oct;64(4):489-92.
PubMed 6483296Johnson JW, Daikoku NH, Niebyl JR, Johnson TR Jr, Khouzami VA, Witter FR. Premature rupture of the membranes and prolonged latency. Obstet Gynecol. 1981 May;57(5):547-56.
PubMed 7219903Kavanagh J, Kelly AJ, Thomas J. Breast stimulation for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD003392. doi: 10.1002/14651858.CD003392.pub2.
PubMed 16034897Leake RD, Buster JE, Fisher DA. The oxytocin secretory response to breast stimulation in women during the menstrual cycle. Am J Obstet Gynecol. 1984 Feb 15;148(4):457-60. doi: 10.1016/0002-9378(84)90726-9.
PubMed 6696003Mishanina E, Rogozinska E, Thatthi T, Uddin-Khan R, Khan KS, Meads C. Use of labour induction and risk of cesarean delivery: a systematic review and meta-analysis. CMAJ. 2014 Jun 10;186(9):665-73. doi: 10.1503/cmaj.130925. Epub 2014 Apr 28.
PubMed 24778358Salmon YM, Kee WH, Tan SL, Jen SW. Cervical ripening by breast stimulation. Obstet Gynecol. 1986 Jan;67(1):21-4.
PubMed 3940333Viegas OA, Arulkumaran S, Gibb DM, Ratnam SS. Nipple stimulation in late pregnancy causing uterine hyperstimulation and profound fetal bradycardia. Br J Obstet Gynaecol. 1984 Apr;91(4):364-6. doi: 10.1111/j.1471-0528.1984.tb05924.x.
PubMed 6712896
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Nipple Stimulation Shorten Time to Vaginal Birth in Women With Term PROM? (NIPROM Study)
- ClinicalTrials.gov ID
- NCT03025581
- Acronym / sponsor ID
- NIPROM / 0091-HYMC
- Conditions
- Premature Rupture of Fetal Membranes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Study start
- Jan 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 19 Jan 2017 (estimated)
- 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.
Premature Rupture of Membranes (PROM) is defined as the rupture of membranes before the onset of regular uterine contractions.
PROM occurs in approximately 10% of all pregnancies (ranging from 2.7% to 17%), with 60% to 80% of cases occurring at term. Approximately 90% of patients' experience PROM enter spontaneous labor within 24 hours, but disagreement exists among health care providers on the optimal management of women with PROM, particularly the need for and timing of inductions.
Nipple stimulation is a non-medical natural method for induction of labor. Previous studies demonstrated its effectiveness for initiating labor within 72 hours in women with favorable cervices. The actual mechanism by which such a technique results in cervical ripening is not well understood.
In this study, we aim to assess the effectiveness of nipple stimulation in gravid women with term PROM choosing expectant management.
Detailed description
The participants in the study will be randomized into two groups of expectant management (patients desire an active approach will be excluded).
All eligible participants will be randomly allocated to either intervention or control group. They will be followed from the time of presentation with rupture of membranes at the ER and until the time of delivery. Prophylactic antibiotics will be administered after 18 hours from rupture of membranes as per departmental policy.
On admission, and after validating inclusion criteria, women will be offered to join the study. For the intervention group women will be instructed to gently massage alternate breasts, especially around the nipples for 15 minutes every 6 hours until the appearance of regular contractions but not more than 24 hours. Moist cloth or lubricating or moisturizing cream will be offered to facilitate the procedure according to individual preferences. In the control group all participants will be asked to avoid any breast stimulation during the study period.
For both groups maternal surveillance will include obstetrician assessment every 6 hours or per maternal request if painful contractions. Every assessment will include documenting maternal vital signs, sense of contraction, fetal cardiotocographic assessment and vaginal examination if painful contractions. After delivery,all participants will be requested to fill a satisfaction questionnaire.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Active comparator | Other: Nipple stimulationNipple stimulation. |
| Control group | No intervention | –No intervention (expectant management only). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Primagravidas at term (>37) weeks having PROM
- Singleton pregnancies
- Cephalic presentation
- Unfavorable cervix (Bishop score <7)
- Desire an expectant management
Key exclusion criteria (6 listed)
- Prior cesarean section/ uterine rupture / transmural uterine incision
- Non reassuring fetal heart rate monitoring (Category III)
- Signs of fetal or maternal infection
- Time elapsed since PROM > 6 hours
- Meconium or blood-stained amniotic fluid
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 |
|---|---|---|
| Nipple stimulationFor the intervention group participants will be instructed to gently massage alternate breasts, especially around the nipples for 15 minutes every 6 hours until the appearance of regular contractions but not more than 24 hours. Moist cloth or lubricating or moisturizing cream will be offered to facilitate the procedure according to individual preferences. In the control group all participants will be asked to avoid any breast stimulation during the study period. | Other | Intervention group |
Primary outcome
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- Results publication: PubMed 8598837Hannah ME, Ohlsson A, Farine D, Hewson SA, Hodnett ED, Myhr TL, Wang EE, Weston JA, Willan AR. Induction of labor compared with expectant management for prelabor rupture of the membranes at term. TERMPROM Study Group. N Engl J Med. 1996 Apr 18;334(16):1005-10. doi: 10.1056/NEJM199604183341601.
- Results publication: PubMed 23583208Cahill AG, Tuuli MG. Labor in 2013: the new frontier. Am J Obstet Gynecol. 2013 Dec;209(6):531-4. doi: 10.1016/j.ajog.2013.04.016. Epub 2013 Apr 10.
- Results publication: PubMed 2618602Christensson K, Nilsson BA, Stock S, Matthiesen AS, Uvnas-Moberg K. Effect of nipple stimulation on uterine activity and on plasma levels of oxytocin in full term, healthy, pregnant women. Acta Obstet Gynecol Scand. 1989;68(3):205-10. doi: 10.3109/00016348909020990.
- Results publication: PubMed 6338721Elliott JP, Flaherty JF. The use of breast stimulation to ripen the cervix in term pregnancies. Am J Obstet Gynecol. 1983 Mar 1;145(5):553-6. doi: 10.1016/0002-9378(83)91194-8.
- Results publication: PubMed 6377899Elliott JP, Flaherty JF. The use of breast stimulation to prevent postdate pregnancy. Am J Obstet Gynecol. 1984 Jul 15;149(6):628-32. doi: 10.1016/0002-9378(84)90247-3.
- Results publication: PubMed 6483296Hill WC, Moenning RK, Katz M, Kitzmiller JL. Characteristics of uterine activity during the breast stimulation stress test. Obstet Gynecol. 1984 Oct;64(4):489-92.
- Results publication: PubMed 7219903Johnson JW, Daikoku NH, Niebyl JR, Johnson TR Jr, Khouzami VA, Witter FR. Premature rupture of the membranes and prolonged latency. Obstet Gynecol. 1981 May;57(5):547-56.
- Results publication: PubMed 16034897Kavanagh J, Kelly AJ, Thomas J. Breast stimulation for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2005 Jul 20;2005(3):CD003392. doi: 10.1002/14651858.CD003392.pub2.
- Results publication: PubMed 6696003Leake RD, Buster JE, Fisher DA. The oxytocin secretory response to breast stimulation in women during the menstrual cycle. Am J Obstet Gynecol. 1984 Feb 15;148(4):457-60. doi: 10.1016/0002-9378(84)90726-9.
- Results publication: PubMed 24778358Mishanina E, Rogozinska E, Thatthi T, Uddin-Khan R, Khan KS, Meads C. Use of labour induction and risk of cesarean delivery: a systematic review and meta-analysis. CMAJ. 2014 Jun 10;186(9):665-73. doi: 10.1503/cmaj.130925. Epub 2014 Apr 28.
- Results publication: PubMed 3940333Salmon YM, Kee WH, Tan SL, Jen SW. Cervical ripening by breast stimulation. Obstet Gynecol. 1986 Jan;67(1):21-4.
- Results publication: PubMed 6712896Viegas OA, Arulkumaran S, Gibb DM, Ratnam SS. Nipple stimulation in late pregnancy causing uterine hyperstimulation and profound fetal bradycardia. Br J Obstet Gynaecol. 1984 Apr;91(4):364-6. doi: 10.1111/j.1471-0528.1984.tb05924.x.
- Individual participant dataSharing planned: No
Related trials for Premature Rupture of Fetal Membranes
RecruitingPhase 3
Selective Antibiotics When Symptoms Develop Versus Universal Antibiotics for Preterm Neonates
Sepsis, PROM, Preterm (Pregnancy)
Recruiting
Amnioinfusion for Chorioamnionitis: Targeting Neonatal Brain Injury Biomarkers
Chorioamnionitis Affecting Fetus or Newborn, Amnioinfusion
Active, not recruitingPhase 3
Erythromycin Versus Azithromycin for Preterm Prelabor Rupture of Membranes
Premature Rupture of Membrane
Not yet recruitingObservational study
Preterm Parturation Study
Preterm Parturation, Preterm Premature Rupture of Membranes (PPROM)
Not yet recruitingObservational study
Prediction of Latency Interval in Patients With Preterm Prelabor Rupture of Membranes
Preterm Prelabor Rupture of Membranes (PPROM)
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. This study is not recruiting at the moment.
Ofer Limonad, M.D contact
Esti Maor, M.D contact
Mordechai Hallak, M.D principal investigator
Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, Hadera
Rinat Gabbay, M.D study director
Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, Hadera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nipple stimulation in people with Premature Rupture of Fetal Membranes, run by Hillel Yaffe Medical Center at 1 site 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ofer Limonad, M.D (oferlimonad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Abnormal Laboratory Values and/or Adverse Events That Are Related to Treatment (time frame: One year). 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 NCT03025581, which also lists 12 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 19 Jan 2017.