ParturitionPhase 4NCT06069596
Evaluation of the Effectiveness of Obstetric Lubricant Gel in Labor in Nulliparous and Primiparous Women: A Randomized Controlled Study
A Phase 4 study testing Natalis Obstetric Lubrican Gel in people with Parturition and Obstetric; Injury Pelvic Floor, run by Ankara University.
Trial summary
The investigators hypothesized that the application of lubricant gels at the beginning of the active phase of the labor may reduce duration of the delivery and episiotomy rates. The aim of this study is to investigate and confirm this hypothesis through a randomised controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Parturition, Obstetric; Injury Pelvic Floor
- What is being tested?
- Natalis Obstetric Lubrican Gel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 15 Jul 2018
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult
Who may be able to join
- Nulliparous and primiparous singleton pregnancies between 37 and 41 weeks + six days of gestation and vertex presentation of fetus with an estimated birth weight of 2000 - 4500g were included in the study
Who cannot join
- Multiparous pregnancies and women who had ceserean section before and/or contraindication for vaginal delivery were excluded from the study.
About this study
The investigators hypothesized that the application of lubricant gels at the beginning of the active phase of the labor may reduce duration of the delivery and episiotomy rates. The aim of this study is to investigate and confirm this hypothesis through a randomised controlled trial.
All participants in the study received standard routine antepartum care in the delivery room. Obstetric lubricant gel was applied to patients in the study groups, which had 47 nulliparous and 50 primiparous patients. Perinatal outcomes were compared between the groups.
Read the detailed description
The participants were divided into two groups based on their parity: nulliparous and primiparous. Initially, each group had 110 participants. Nulliparous and primiparous groups were randomly assigned to two groups as study and control groups using a computer-generated random number table. In this randomized controlled trial, participant allocation was carried out using a computer program to ensure a randomized and unbiased selection process. The randomization procedure was conducted in a double-blind manner, with the study investigators remaining unaware of the allocation until the conclusion of the study. All participants in the study received standard routine antepartum care in the delivery room. Among all patients, 25 participants were lost to follow-up during the study. Consequently, obstetric lubricant gel was applied to patients in the study groups, which included 47 nulliparous and 50 primiparous patients. Perinatal outcomes were compared between the groups
- Conditions
- Parturition, Obstetric; Injury Pelvic Floor
- Being tested
- Natalis Obstetric Lubrican Gel
- Keywords
- birth, parturition, obstetric lubricant gel, duration of second stage of labor, labor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Natalis Obstetric Lubrican GelCombination product
The obstetric lubricant gel was applied to the vaginal canal with a special applicator at the beginning of the active phase of the labor. The gel used in the study was highly viscose and isotonic with a slight acid pH of 6.0 - 6.7 and contained hydroxyethylcellulose, propylene glycol, glycerin. The gel box contained a sterile syringe (15 ml) and a flexible applicator.
| Study group | Role | What they receive |
|---|---|---|
| Study group | Active comparator | obstetric lubricant gel was applied to patients in the study groups, which had 47 nulliparous and 50 primiparous patients. Receives: Combination Product: Natalis Obstetric Lubrican Gel |
| Control group | No intervention | obstetric lubricant gel was not applied to patients in the control groups, which had 55 nulliparous and 43 primiparous patients. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The duration of the active phase of the first stage of labor was compared between the study and control groups
The active phase of labor begins when the cervical dilation is between 4-6 cm and refers to the time elapsed until full cervical dilation.
Measured: 0 to 600 minutes
The duration of the second stage of labor was compared between the study and control groups
The second stage of labor begins when the cervical dilation is complete and continues until the birth of the newborn.
Measured: 0 to 240 minutes
Secondary outcomes (1)
Episiotomy rates
differences between study and control groups
Measured: Episiotomy is a technique performed during the second stage of labor.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start1 Jan 2017
- Primary completion30 Apr 2017
- Study completion15 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ParturitionStudies of the same condition, open and under way.
- More trials run by Ankara UniversityThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The participants were divided into two groups based on their parity; nulliparous and primiparous. At the outset, each group had 110 participants. Nulliparous and primiparous groups were randomly assigned to two groups as study and control groups by using a computer generating random number table. Obstetric lubricant gel was applied to patients in the study groups. Perinatal outcomes and durations of the labor were compared between study and control groups.
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, kaan baydemir, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06069596
- Sponsor's protocol ID
- 290819912
- Status last verified
- Oct 2023
- First submitted
- 28 Sep 2023
- Last updated
- 12 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Seval MM, Yuce T, Yakistiran B, Sukur YE, Ozmen B, Atabekoglu C, Koc A, Soylemez F. Effects of obstetric gel on the process and duration of labour in pregnant women: Randomised controlled trial. J Obstet Gynaecol. 2017 Aug;37(6):714-718. doi: 10.1080/01443615.2017.1288711. Epub 2017 Mar 21.
PubMed 28325124Azarkish F, Janghorban R, Bozorgzadeh S, Merbalouchzai F, Razavi M, Badiee M. Effect of lubricant gel on the length of the first stage of labour and perineal trauma in primiparous women. J Obstet Gynaecol. 2022 Jul;42(5):867-871. doi: 10.1080/01443615.2021.1946021. Epub 2021 Sep 27.
PubMed 34569413
Study at a glance
From the registry record, last updated by the sponsor on 12 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Obstetric Lubricant Gel in Labor in Nulliparous and Primiparous Women: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT06069596
- Acronym / sponsor ID
- 290819912
- Conditions
- Parturition, Obstetric; Injury Pelvic Floor
- Keywords
- birth, parturition, obstetric lubricant gel, duration of second stage of labor, labor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Apr 2017 (actual)
- Study completion
- 15 Jul 2018 (actual)
- First posted
- 6 Oct 2023 (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 investigators hypothesized that the application of lubricant gels at the beginning of the active phase of the labor may reduce duration of the delivery and episiotomy rates. The aim of this study is to investigate and confirm this hypothesis through a randomised controlled trial.
All participants in the study received standard routine antepartum care in the delivery room. Obstetric lubricant gel was applied to patients in the study groups, which had 47 nulliparous and 50 primiparous patients. Perinatal outcomes were compared between the groups.
Detailed description
The participants were divided into two groups based on their parity: nulliparous and primiparous. Initially, each group had 110 participants. Nulliparous and primiparous groups were randomly assigned to two groups as study and control groups using a computer-generated random number table. In this randomized controlled trial, participant allocation was carried out using a computer program to ensure a randomized and unbiased selection process. The randomization procedure was conducted in a double-blind manner, with the study investigators remaining unaware of the allocation until the conclusion of the study. All participants in the study received standard routine antepartum care in the delivery room. Among all patients, 25 participants were lost to follow-up during the study. Consequently, obstetric lubricant gel was applied to patients in the study groups, which included 47 nulliparous and 50 primiparous patients. Perinatal outcomes were compared between the groups
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The participants were divided into two groups based on their parity; nulliparous and primiparous. At the outset, each group had 110 participants. Nulliparous and primiparous groups were randomly assigned to two groups as study and control groups by using a computer generating random number table. Obstetric lubricant gel was applied to patients in the study groups. Perinatal outcomes and durations of the labor were compared between study and control groups.
| Arm | Type | Receives |
|---|---|---|
| Study group | Active comparator | Combination Product: Natalis Obstetric Lubrican Gelobstetric lubricant gel was applied to patients in the study groups, which had 47 nulliparous and 50 primiparous patients. |
| Control group | No intervention | –obstetric lubricant gel was not applied to patients in the control groups, which had 55 nulliparous and 43 primiparous patients. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Nulliparous and primiparous singleton pregnancies between 37 and 41 weeks + six days of gestation and vertex presentation of fetus with an estimated birth weight of 2000 - 4500g were included in the study
Key exclusion criteria (1 listed)
- Multiparous pregnancies and women who had ceserean section before and/or contraindication for vaginal delivery were excluded from the study.
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 |
|---|---|---|
| Natalis Obstetric Lubrican GelThe obstetric lubricant gel was applied to the vaginal canal with a special applicator at the beginning of the active phase of the labor. The gel used in the study was highly viscose and isotonic with a slight acid pH of 6.0 - 6.7 and contained hydroxyethylcellulose, propylene glycol, glycerin. The gel box contained a sterile syringe (15 ml) and a flexible applicator. | Combination product | Study group |
Primary outcome
The duration of the active phase of the first stage of labor was compared between the study and control groups
Time frame: 0 to 600 minutes
The active phase of labor begins when the cervical dilation is between 4-6 cm and refers to the time elapsed until full cervical dilation.
The duration of the second stage of labor was compared between the study and control groups
Time frame: 0 to 240 minutes
The second stage of labor begins when the cervical dilation is complete and continues until the birth of the newborn.
1 secondary outcome
Episiotomy rates
Time frame: Episiotomy is a technique performed during the second stage of labor.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Oct 2023.
- Background: PubMed 28325124Seval MM, Yuce T, Yakistiran B, Sukur YE, Ozmen B, Atabekoglu C, Koc A, Soylemez F. Effects of obstetric gel on the process and duration of labour in pregnant women: Randomised controlled trial. J Obstet Gynaecol. 2017 Aug;37(6):714-718. doi: 10.1080/01443615.2017.1288711. Epub 2017 Mar 21.
- Background: PubMed 34569413Azarkish F, Janghorban R, Bozorgzadeh S, Merbalouchzai F, Razavi M, Badiee M. Effect of lubricant gel on the length of the first stage of labour and perineal trauma in primiparous women. J Obstet Gynaecol. 2022 Jul;42(5):867-871. doi: 10.1080/01443615.2021.1946021. Epub 2021 Sep 27.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Natalis Obstetric Lubrican Gel in people with Parturition and Obstetric; Injury Pelvic Floor, run by Ankara University.
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 12 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The duration of the active phase of the first stage of labor was compared between the study and control groups (time frame: 0 to 600 minutes). The study lists 2 primary outcomes in all. 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 NCT06069596, which also lists 2 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 12 Oct 2023.