Disorder of Amniotic Cavity and/or MembraneNCT01309308
Sweeping the Membranes, Cervical Length and Duration of Labor
A study testing sweeping the membranes and No sweeping group in people with Disorder of Amniotic Cavity and/or Membrane, run by Huriye Ayse Parlakgumus at 1 site in Turkey (Türkiye).
Trial summary
Sweeping the membranes in term pregnancy may shorten the cervix and reduce the time to delivery. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Disorder of Amniotic Cavity and/or Membrane
- What is being tested?
- sweeping the membranes and No sweeping group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2011to Mar 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- The patients who completed the 38th week of pregnancy, otherwise healthy gravida who have no contraindication to vaginal delivery.
Who cannot join
- Women who have chronic disease complicating pregnancy, multiple pregnancies and in whom vaginal delivery is contraindicated.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Baskent Universitesi Seyhan Arastirma ve Uygulama Hastanesi
Adana, 01110
About this study
Official title: The Impact of Sweeping the Membranes on Cervical Length and Labor: A Randomized Clinical Trial
Sweeping the membranes in term pregnancy may shorten the cervix and reduce the time to delivery.
Read the detailed description
Cervical length will be measured in both groups. The membranes will be swept in pregnancies beyond 38 weeks by digital examination in the study group. The control group will only be examined for Bishop score. Two days later cervical length will be Measured once more.
- Being tested
- sweeping the membranes, No sweeping group
- Keywords
- cervical length, sweeping the membranes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sweeping the membranesProcedure or surgery
Also called stripping the membranes, digital examination
The cervical length will be measured and the patient will be examined to determine the Bishop score. Later the the membranes will be swept.
No sweeping groupOther
Also called bishop score, digital examination
Cervical length will be measured by transvaginal USG and the patient will be examined to determine the Bishop score.
| Study group | Role | What they receive |
|---|---|---|
| The membranes swept group | Experimental | This group will have a sweeping of the membranes after the 38th of gestation at hospital, in order to reduce the latency period until labor. Sweeping of the membranes is done by the insertion of examiners finger between the decidua and fetal membranes and by the circular movement of the finger, the membranes are detached from the decidua. Receives: Procedure: sweeping the membranes |
| No sweeping group | Sham comparator | This group will not have sweeping of the membranes, will only have vaginal ultrasound Receives: Other: No sweeping group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cervical Shortening
Cervix 1 was measured at the sagittal plane of cervix from external to the internal os. Two days later cervix 2 was measured the same way. The cervical shortening was calculated from subtracting cervix 1 from cervix 2.
Measured: 2days
Secondary outcomes (1)
The Duration of Latency Until Labor
The period (in days) from the last cervical measurement to the start of second phase of labor.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2011 (estimated)
- Study startFeb 2011
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disorder of Amniotic Cavity and/or MembraneStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Huriye Ayse Parlakgumus
- Sponsor type
- University, hospital or other
- Collaborators
- Baskent University
- Responsible party
- Sponsor-investigator, Huriye Ayse Parlakgumus, Baskent University
- Investigators
- Huriye A Parlakgumus, MD, Principal investigator, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01309308
- Sponsor's protocol ID
- KA 09/248
- Status last verified
- Oct 2011
- First submitted
- 4 Mar 2011
- Last updated
- 7 Oct 2011
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Parlakgumus HA, Yalcinkaya C, Haydardedeoglu B, Tarim E. The impact of sweeping the membranes on cervical length and labor: a randomized clinical trial. Ginekol Pol. 2014 Sep;85(9):682-7.
PubMed 25322540
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Sweeping the Membranes on Cervical Length and Labor: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT01309308
- Acronym / sponsor ID
- KA 09/248
- Keywords
- cervical length, sweeping the membranes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Huriye Ayse ParlakgumusUniversity, hospital or other
- Collaborators
- Baskent University
- Study start
- Feb 2011
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 7 Mar 2011 (estimated)
- Results
- Posted 3 Oct 2011
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Sweeping the membranes in term pregnancy may shorten the cervix and reduce the time to delivery.
Detailed description
Cervical length will be measured in both groups. The membranes will be swept in pregnancies beyond 38 weeks by digital examination in the study group. The control group will only be examined for Bishop score. Two days later cervical length will be Measured once more.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The membranes swept group | Experimental | Procedure: sweeping the membranesThis group will have a sweeping of the membranes after the 38th of gestation at hospital, in order to reduce the latency period until labor. Sweeping of the membranes is done by the insertion of examiners finger between the decidua and fetal membranes and by the circular movement of the finger, the membranes are detached from the decidua. |
| No sweeping group | Sham comparator | Other: No sweeping groupThis group will not have sweeping of the membranes, will only have vaginal ultrasound |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The patients who completed the 38th week of pregnancy, otherwise healthy gravida who have no contraindication to vaginal delivery.
Key exclusion criteria (1 listed)
- Women who have chronic disease complicating pregnancy, multiple pregnancies and in whom vaginal delivery is contraindicated.
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 |
|---|---|---|
| sweeping the membranesAlso: stripping the membranes, digital examinationThe cervical length will be measured and the patient will be examined to determine the Bishop score. Later the the membranes will be swept. | Procedure or surgery | The membranes swept group |
| No sweeping groupAlso: bishop score, digital examinationCervical length will be measured by transvaginal USG and the patient will be examined to determine the Bishop score. | Other | No sweeping group |
Primary outcome
Cervical Shortening
Time frame: 2days
Cervix 1 was measured at the sagittal plane of cervix from external to the internal os. Two days later cervix 2 was measured the same way. The cervical shortening was calculated from subtracting cervix 1 from cervix 2.
1 secondary outcome
The Duration of Latency Until Labor
Time frame: 15 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2011.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25322540Parlakgumus HA, Yalcinkaya C, Haydardedeoglu B, Tarim E. The impact of sweeping the membranes on cervical length and labor: a randomized clinical trial. Ginekol Pol. 2014 Sep;85(9):682-7.
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.
Huriye A Parlakgumus, MD principal investigator
Baskent 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 sweeping the membranes and No sweeping group in people with Disorder of Amniotic Cavity and/or Membrane, run by Huriye Ayse Parlakgumus 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 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 7 Oct 2011. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 3 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Cervical Shortening (time frame: 2days). 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 NCT01309308, which also lists 1 linked publication.
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 7 Oct 2011.