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CompletedNCT01309308Updated Oct 7, 2011Results posted

Sweeping the Membranes, Cervical Length and Duration of Labor

An interventional study of sweeping the membranes and No sweeping group in Disorder of Amniotic Cavity and/or Membrane, sponsored by Huriye Ayse Parlakgumus. Completed at 1 site in Turkey. Open to female participants aged 18 Years to 42 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-10-07.

Sponsored by Huriye Ayse Parlakgumus · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 42 Years
Sex
Female
01

Study summary

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.

02

Conditions studied

  • Disorder of Amniotic Cavity and/or Membrane

Keywords

  • cervical length
  • sweeping the membranes
03

In context

Lead sponsor

This is the only study on the registry with Huriye Ayse Parlakgumus as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 42 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • The patients who completed the 38th week of pregnancy, otherwise healthy gravida who have no contraindication to vaginal delivery.

Exclusion criteria

Exclusion Criteria:

  • Women who have chronic disease complicating pregnancy, multiple pregnancies and in whom vaginal delivery is contraindicated.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
150 participants (actual)

Study arms

  • Experimental
    The membranes swept group

    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.

    Procedure: sweeping the membranes

  • Sham comparator
    No sweeping group

    This group will not have sweeping of the membranes, will only have vaginal ultrasound

    Other: No sweeping group

Interventions

  • Proceduresweeping the membranes

    The cervical length will be measured and the patient will be examined to determine the Bishop score. Later the the membranes will be swept.

    Also known as: stripping the membranes, digital examination

  • OtherNo sweeping group

    Cervical length will be measured by transvaginal USG and the patient will be examined to determine the Bishop score.

    Also known as: bishop score, digital examination

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: 15 days

07

Results

Posted Oct 3, 2011
Limitations and caveats
Patients who did not attend the second examination, patients who did not deliver in our clinic are excluded

Participant flow

february-March 2011- department of obstetrics and gynecology

Participant flow — Overall Study
MilestoneThe Membranes Swept GroupNo Sweeping Group
Started7575
Completed6971
Not completed64
Withdrew: Lost to follow-up64

Outcome measures

PrimaryCervical 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.

Time frame:
2days
Reported as:
Mean · millimeters
Cervical Shortening
millimetersSweepingNot Swept
cervix127.45 ± 8.3929.61 ± 8.97
cervix223.30 ± 8.8423.88 ± 8.52
cervical shortening5.15 ± 4.425.72 ± 4.37
SecondaryThe Duration of Latency Until Labor

The period (in days) from the last cervical measurement to the start of second phase of labor.

Time frame:
15 days
Reported as:
Mean · days
The Duration of Latency Until Labor
daysSweepingNot Swept
The Duration of Latency Until Labor6.33 ± 4.575.69 ± 4.11

Adverse events

Non-serious events are listed at a 1% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
The Membranes Swept Group—0/75 (0%)0/75 (0%)
No Sweeping Group—0/75 (0%)0/75 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)The Membranes Swept GroupNo Sweeping GroupTotal
<=18 years000
Between 18 and 65 years7575150
>=65 years000
Age Continuous
Age Continuous(years)The Membranes Swept GroupNo Sweeping GroupTotal
Mean27.25 ± 5.0628.11 ± 4.7827.69 ± 4.92
Sex: Female, Male
Sex: Female, Male(Participants)The Membranes Swept GroupNo Sweeping GroupTotal
Female7575150
Male000
Region of Enrollment
Region of Enrollment(participants)The Membranes Swept GroupNo Sweeping GroupTotal
Turkey7575150
08

Study locations

1 site
  • Baskent Universitesi Seyhan Arastirma ve Uygulama Hastanesi
    Adana, 01110, Turkey
09

References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 7, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT01309308
Lead sponsor
Huriye Ayse Parlakgumus
Collaborators
Baskent University
Responsible party
Huriye Ayse Parlakgumus (MD, Baskent University) — Sponsor-investigator
First posted
Mar 7, 2011
Start date
Feb 2011
Primary completion
Mar 2011
Completion
Mar 2011
Results posted
Oct 3, 2011
Last update
Oct 7, 2011

Study contacts

Huriye A Parlakgumus, MD
principal investigator · Baskent University

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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