Early LaborNCT03517696
Membrane Sweeping in Early Labor and Delivery Outcomes
A study testing Membrane sweeping in people with Early Labor, run by Johns Hopkins University at 1 site in United States.
Trial summary
Membrane sweeping is a routine procedure in obstetrics in term patients. It has been shown to be effective in decreasing post term gestation and in increasing rate of spontaneous vaginal delivery when used in setting of induction of labor in nulliparous patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Early Labor
- What is being tested?
- Membrane sweeping
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 20 May 2018to 25 Feb 2020
- 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 50 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Singleton pregnancy at or after 39 weeks gestation, intact membranes, cephalic presentation, nulliparous, Bishop score <7, English or Spanish speaking
Who cannot join
- Prior uterine surgery precluding vaginal delivery, maternal condition precluding vaginal delivery, fetal anomaly, prior membrane stripping
Trial locations and contacts
1 site in 1 country.
About this study
Membrane sweeping is a routine procedure in obstetrics in term patients. It has been shown to be effective in decreasing post term gestation and in increasing rate of spontaneous vaginal delivery when used in setting of induction of labor in nulliparous patients. The goal of this study is to determine if membranes sweeping in early labor is effective in improving delivery outcomes including decreasing rate of cesarean section.
Read the detailed description
This is a non-blinded randomized controlled trial. Participants will be recruited at time of presentation to triage for labor evaluation after cervical exam. Patients with a term, singleton pregnancy who present with regular, painful contractions and a Bishop score < 7 will be recruited to the study. A random number generator will be used to create a list of random binary numbers. If the patient agrees to the study, the random number list will be used to assign the participant to membrane sweeping or no membrane sweeping. Participants assigned to membrane sweeping will have an additional exam during their initial evaluation in which the membranes will be separated from the cervix and lower part of the uterus with a finger inserted into the cervical os. This would be done with at least one rotation counterclockwise and one rotation clockwise. Those not assigned to membrane sweeping will not have an additional exam. Patients will then be managed as per their primary Obstetrics (OB) provider with the exception of no further membrane sweeping throughout the labor course.
Participants are only required to participate during initial evaluation and randomization. No extra study visits are required.
Due to the nature of the intervention, which requires a provider to perform a procedure, blinding will not be possible for this trial.
No therapy will be withheld for any patients. Their labor course will be managed as per their primary provider using standards of care.
Non-treatment group is necessary in order to exam the difference of effects between membrane sweeping and no membrane sweeping.
Patients will be removed from the study if they chose to withdraw their participation.
Participants will resume care as normal regardless of withdrawing study participation.
- Conditions
- Early Labor
- Being tested
- Membrane sweeping
- Medical subject headings
- Obstetric Labor, Premature
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Membrane sweepingProcedure or surgery
Participants assigned to membrane sweeping will have an additional exam during their initial evaluation in which the membranes will be separated from the cervix and lower part of the uterus with a finger inserted into the cervical os. This would be done with at least one rotation counterclockwise and one rotation clockwise.
| Study group | Role | What they receive |
|---|---|---|
| Membrane Sweeping | Active comparator | Membrane sweeping Receives: Procedure: Membrane sweeping |
| Control | No intervention | Routine vaginal exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decrease in Cesarean delivery rate
Decrease in Cesarean delivery rate
Measured: Up to 3 weeks
Secondary outcomes (3)
Time to delivery
Length of labor from randomization to delivery
Measured: Up to 3 weeks
Operative vaginal delivery rate
Assess a decrease in operative vaginal delivery
Measured: Up to 3 weeks
Labor augmentation rate reduction
Assess the reduction in the rate of labor augmentation ( via the use of oxytocin and/or amniotomy)
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2018
- Study start20 May 2018
- Primary completion25 Feb 2020
- Study completion25 Feb 2020
Why it stopped: Study IRB approval expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Early LaborStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Non-blinded Randomized Controlled Trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeanne S Sheffield, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03517696
- Sponsor's protocol ID
- IRB00153394
- Status last verified
- Jul 2020
- First submitted
- 18 Apr 2018
- Last updated
- 18 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Spong CY, Berghella V, Wenstrom KD, Mercer BM, Saade GR. Preventing the first cesarean delivery: summary of a joint Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, and American College of Obstetricians and Gynecologists Workshop. Obstet Gynecol. 2012 Nov;120(5):1181-93. doi: 10.1097/aog.0b013e3182704880.
PubMed 23090537ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.
PubMed 19623003Berghella V, Baxter JK, Chauhan SP. Evidence-based labor and delivery management. Am J Obstet Gynecol. 2008 Nov;199(5):445-54. doi: 10.1016/j.ajog.2008.06.093.
PubMed 18984077Boulvain M, Stan C, Irion O. Membrane sweeping for induction of labour. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD000451. doi: 10.1002/14651858.CD000451.pub2.
PubMed 15674873Foong LC, Vanaja K, Tan G, Chua S. Membrane sweeping in conjunction with labor induction. Obstet Gynecol. 2000 Oct;96(4):539-42. doi: 10.1016/s0029-7844(00)00995-9.
PubMed 11004355Tan PC, Jacob R, Omar SZ. Membrane sweeping at initiation of formal labor induction: a randomized controlled trial. Obstet Gynecol. 2006 Mar;107(3):569-77. doi: 10.1097/01.AOG.0000200094.89388.70.
PubMed 16507926Al-Harmi J, Chibber R, Fouda M, Mohammed ZK, El-Saleh E, Tasneem A. Is membrane sweeping beneficial at the initiation of labor induction? J Matern Fetal Neonatal Med. 2015 Jul;28(10):1214-8. doi: 10.3109/14767058.2014.947951. Epub 2014 Aug 18.
PubMed 25082072Chanrachakul B, Suthutvoravut S, Sangthawan M, Herabutya Y. Effect of lower uterine segment sweeping on progress of labor in nullipara. J Med Assoc Thai. 2001 Nov;84(11):1582-6.
PubMed 11853301
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Membrane Sweeping in Early Labor and Delivery Outcomes
- ClinicalTrials.gov ID
- NCT03517696
- Acronym / sponsor ID
- IRB00153394
- Conditions
- Early Labor
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study IRB approval expired
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Study start
- 20 May 2018 (actual)
- Primary completion
- 25 Feb 2020 (actual)
- Study completion
- 25 Feb 2020 (actual)
- First posted
- 7 May 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.
Membrane sweeping is a routine procedure in obstetrics in term patients. It has been shown to be effective in decreasing post term gestation and in increasing rate of spontaneous vaginal delivery when used in setting of induction of labor in nulliparous patients. The goal of this study is to determine if membranes sweeping in early labor is effective in improving delivery outcomes including decreasing rate of cesarean section.
Detailed description
This is a non-blinded randomized controlled trial. Participants will be recruited at time of presentation to triage for labor evaluation after cervical exam. Patients with a term, singleton pregnancy who present with regular, painful contractions and a Bishop score < 7 will be recruited to the study. A random number generator will be used to create a list of random binary numbers. If the patient agrees to the study, the random number list will be used to assign the participant to membrane sweeping or no membrane sweeping. Participants assigned to membrane sweeping will have an additional exam during their initial evaluation in which the membranes will be separated from the cervix and lower part of the uterus with a finger inserted into the cervical os. This would be done with at least one rotation counterclockwise and one rotation clockwise. Those not assigned to membrane sweeping will not have an additional exam. Patients will then be managed as per their primary Obstetrics (OB) provider with the exception of no further membrane sweeping throughout the labor course.
Participants are only required to participate during initial evaluation and randomization. No extra study visits are required.
Due to the nature of the intervention, which requires a provider to perform a procedure, blinding will not be possible for this trial.
No therapy will be withheld for any patients. Their labor course will be managed as per their primary provider using standards of care.
Non-treatment group is necessary in order to exam the difference of effects between membrane sweeping and no membrane sweeping.
Patients will be removed from the study if they chose to withdraw their participation.
Participants will resume care as normal regardless of withdrawing study participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Non-blinded Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Membrane Sweeping | Active comparator | Procedure: Membrane sweepingMembrane sweeping |
| Control | No intervention | –Routine vaginal exam |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Singleton pregnancy at or after 39 weeks gestation, intact membranes, cephalic presentation, nulliparous, Bishop score <7, English or Spanish speaking
Key exclusion criteria (1 listed)
- Prior uterine surgery precluding vaginal delivery, maternal condition precluding vaginal delivery, fetal anomaly, prior membrane stripping
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 |
|---|---|---|
| Membrane sweepingParticipants assigned to membrane sweeping will have an additional exam during their initial evaluation in which the membranes will be separated from the cervix and lower part of the uterus with a finger inserted into the cervical os. This would be done with at least one rotation counterclockwise and one rotation clockwise. | Procedure or surgery | Membrane Sweeping |
Primary outcome
Decrease in Cesarean delivery rate
Time frame: Up to 3 weeks
Decrease in Cesarean delivery rate
3 secondary outcomes
Time to delivery
Time frame: Up to 3 weeks
Operative vaginal delivery rate
Time frame: Up to 3 weeks
Labor augmentation rate reduction
Time frame: Up to 3 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2020.
- Background: PubMed 23090537Spong CY, Berghella V, Wenstrom KD, Mercer BM, Saade GR. Preventing the first cesarean delivery: summary of a joint Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, and American College of Obstetricians and Gynecologists Workshop. Obstet Gynecol. 2012 Nov;120(5):1181-93. doi: 10.1097/aog.0b013e3182704880.
- Background: PubMed 19623003ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-397. doi: 10.1097/AOG.0b013e3181b48ef5. No abstract available.
- Background: PubMed 18984077Berghella V, Baxter JK, Chauhan SP. Evidence-based labor and delivery management. Am J Obstet Gynecol. 2008 Nov;199(5):445-54. doi: 10.1016/j.ajog.2008.06.093.
- Background: PubMed 15674873Boulvain M, Stan C, Irion O. Membrane sweeping for induction of labour. Cochrane Database Syst Rev. 2005 Jan 25;2005(1):CD000451. doi: 10.1002/14651858.CD000451.pub2.
- Background: PubMed 11004355Foong LC, Vanaja K, Tan G, Chua S. Membrane sweeping in conjunction with labor induction. Obstet Gynecol. 2000 Oct;96(4):539-42. doi: 10.1016/s0029-7844(00)00995-9.
- Background: PubMed 16507926Tan PC, Jacob R, Omar SZ. Membrane sweeping at initiation of formal labor induction: a randomized controlled trial. Obstet Gynecol. 2006 Mar;107(3):569-77. doi: 10.1097/01.AOG.0000200094.89388.70.
- Background: PubMed 25082072Al-Harmi J, Chibber R, Fouda M, Mohammed ZK, El-Saleh E, Tasneem A. Is membrane sweeping beneficial at the initiation of labor induction? J Matern Fetal Neonatal Med. 2015 Jul;28(10):1214-8. doi: 10.3109/14767058.2014.947951. Epub 2014 Aug 18.
- Background: PubMed 11853301Chanrachakul B, Suthutvoravut S, Sangthawan M, Herabutya Y. Effect of lower uterine segment sweeping on progress of labor in nullipara. J Med Assoc Thai. 2001 Nov;84(11):1582-6.
- 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.
Jeanne S Sheffield, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Membrane sweeping in people with Early Labor, run by Johns Hopkins University at 1 site in United States.
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: withdrawn, as of the sponsor's last update on 18 Sep 2020. 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 United States. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Decrease in Cesarean delivery rate (time frame: Up to 3 weeks). 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 NCT03517696, which also lists 8 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 18 Sep 2020.