Delivery, ObstetricNCT03591159
The Effect of Membrane Sweeping on the Delivery Time and the Need of Induction in Term Pregnancy
A study testing Membran Sweeping in people with Delivery, Obstetric, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
Pregnancies that extend beyond 42 weeks of gestation are at an increased risk for poor fetal and maternal outcomes. For decreasing the number of these cases, some labor induction techniques are used. The status of the cervix is an indicator for the success of the induction. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Delivery, Obstetric
- What is being tested?
- Membran Sweeping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 29 May 2018to 1 Dec 2025
- 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-35 years
- Vertex presentation
- No contraindication for vaginal delivery
- No contraindication for labor induction
Who cannot join
- Active vaginal infection
- Previous uterine surgery
- Systemic disease
- Multiple pregnancy
- Fetal anomaly and suspicious fetal health status
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University School of Medicine Department of Obstetrics and Gynecology
Ankara, 06590
About this study
Pregnancies that extend beyond 42 weeks of gestation are at an increased risk for poor fetal and maternal outcomes. For decreasing the number of these cases, some labor induction techniques are used. The status of the cervix is an indicator for the success of the induction. In these study, investigators investigate the effect of membrane sweeping on the need of induction and the delivery time in term pregnancy.
- Conditions
- Delivery, Obstetric
- Being tested
- Membran Sweeping
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Membran SweepingOther
Cervical Membrane Sweeping by digital examination
| Study group | Role | What they receive |
|---|---|---|
| Membrane Sweeping Group | Active comparator | Not described Receives: Other: Membran Sweeping |
| Control Group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Need of Labor Induction.
Patient need induction for delivery or not. If the patient reach 40 weeks 6 days for gestational age and spontaneous delivery doesn't begin spontaneously, labor induction is needed.
Measured: During pregnancy. 40 weeks and 6 days for gestational age
Duration of delivery
The time of the latent and active stage of delivery
Measured: During delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start29 May 2018
- Primary completion1 Jan 2020
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Delivery, ObstetricStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Batuhan Turgay, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03591159
- Sponsor's protocol ID
- 09-604-18
- Status last verified
- Aug 2025
- First submitted
- 19 Jun 2018
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At the end of the study, participant data access is possible by online.
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Membrane Sweeping on the Delivery Time and the Need of Induction in Term Pregnancy
- ClinicalTrials.gov ID
- NCT03591159
- Acronym / sponsor ID
- 09-604-18
- Conditions
- Delivery, Obstetric
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 29 May 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 19 Jul 2018 (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.
Pregnancies that extend beyond 42 weeks of gestation are at an increased risk for poor fetal and maternal outcomes. For decreasing the number of these cases, some labor induction techniques are used. The status of the cervix is an indicator for the success of the induction. In these study, investigators investigate the effect of membrane sweeping on the need of induction and the delivery time in term pregnancy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Membrane Sweeping Group | Active comparator | Other: Membran Sweeping |
| Control Group | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age 18-35 years
- Vertex presentation
- No contraindication for vaginal delivery
- No contraindication for labor induction
Key exclusion criteria (5 listed)
- Active vaginal infection
- Previous uterine surgery
- Systemic disease
- Multiple pregnancy
- Fetal anomaly and suspicious fetal health status
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 |
|---|---|---|
| Membran SweepingCervical Membrane Sweeping by digital examination | Other | Membrane Sweeping Group |
Primary outcome
Need of Labor Induction.
Time frame: During pregnancy. 40 weeks and 6 days for gestational age
Patient need induction for delivery or not. If the patient reach 40 weeks 6 days for gestational age and spontaneous delivery doesn't begin spontaneously, labor induction is needed.
Duration of delivery
Time frame: During delivery
The time of the latent and active stage of delivery
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 Sep 2025.
- Individual participant dataSharing planned: Undecided. At the end of the study, participant data access is possible by online.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Membran Sweeping in people with Delivery, Obstetric, run by Ankara University at 1 site in Turkey (Türkiye).
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 5 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: under way, not looking for participants, as of the sponsor's last update on 8 Sep 2025. 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 Turkey (Türkiye). 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?
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?
Need of Labor Induction. (time frame: During pregnancy. 40 weeks and 6 days for gestational age). 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?
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 Sep 2025.