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CompletedNCT01180023Updated Feb 15, 2013

Membrane Sweeping in Group B Streptococcus (GBS) Positive Patients

An interventional study of Sweeping in Group B Streptococcus, sponsored by George Washington University. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2013-02-15.

Sponsored by George Washington University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
Female
01

Study summary

Sweeping or stripping of the membranes (in this paper referred to as "membrane sweeping") is a widely utilized technique to hasten delivery for women at 37+ weeks gestation. The process of membrane sweeping probably causes release of prostaglandins from the decidua and the cervix. The efficacy of membrane sweeping is well studied, and has been shown to increase the number of patients in labor within 72 hours, reduce the frequency of pregnancy continuing beyond 41 or 42 weeks, and reduce the frequency of formal induction of labor. Thus, it is a safe and practical option for women who wish to avoid inductions of labor or postterm pregnancies.

Group B streptococcus (GBS; streptococcus agalactiae) is a gram positive coccus that frequently colonizes the human genital tract. In pregnant women, GBS can cause urinary tract infections, chorioamnionitis, and postpartum endometritis. Newborn infants can also acquire GBS infection during passage through the vagina. Early onset GBS disease in the newborn can lead to pneumonia, meningitis, and sepsis, all of which can be life-threatening. Early onset GBS disease has become rare since the widespread use of GBS screening and prophylactic treatment of pregnant women.

The relationship between early onset GBS disease and sweeping of the membranes is not known. Based on the theoretical increased risk of bacterial seeding after membrane sweeping, as well as concern for fast labors and inadequate treatment after membrane sweeping, some practitioners choose not to sweep membranes in GBS positive patients. A meta-analysis did not show a difference in neonatal or maternal infection rates between women who underwent membrane sweeping and those who did not. ACOG guidelines state "the risks of membrane stripping in GBS positive patients has not been investigated in well-designed, prospective studies. Therefore, data are insufficient to encourage or discourage this practice".

Specific Aims:

In order to help elucidate the effect of membrane sweeping in GBS positive patients, the investigators propose this prospective randomized trial. The investigators primary objective is to determine whether membrane sweeping in GBS positive women is associated with inadequate antibiotic treatment in labor (defined as less than four hours of antibiotic therapy prior to delivery). The investigators secondary objectives are to measure the effect of membrane sweeping on pregnancy duration, length of labor and adverse events potentially related to membrane sweeping such as maternal chorioamnionitis and neonatal morbidity. Randomization is the real research portion of this study, since offering membrane sweeping is already the standard of care. Patients are followed until the time of delivery, which is within 6 weeks of enrollment for most women.

02

Conditions studied

  • Group B Streptococcus

Keywords

  • GBS
  • Membrane sweeping
03

In context

Lead sponsor

George Washington University is the lead sponsor of 187 studies on the registry; 34 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 11 (85%) have results posted.

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

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
Yes

Inclusion criteria

  • All women presenting to the Medical Faculty Associates outpatient Obstetrics clinic who are 37+ weeks
  • Are at least 18 years of age and can read and write in English
  • Are candidates for vaginal delivery, and qualify for GBS prophylaxis by CDC criteria (any one of the following:

    • have rectovaginal cultures positive for GBS
    • have a GBS UTI this pregnancy
    • have had an infant with GBS disease in a prior delivery) will be offered enrollment in the study.

Exclusion criteria

Exclusion Criteria:

  • Patients who are not candidates for vaginal delivery (placenta previa, breech presentation, planned repeat cesarean), will be excluded from the study.
  • Patients who are HIV positive will also be excluded, since membrane sweeping may have some risks in these patients.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Sweeping

    Procedure: Sweeping

  • No intervention
    No sweeping

Interventions

  • ProcedureSweeping

    Sweeping of membranes during digital exam

06

What researchers measure

Primary outcomes

  1. Adequate antibiotics received in labor

    Charts are reviewed to determine if subjects received appropriate treatment in labor with regards to timing of antibiotic administration

    Time frame: Data collected from chart after patients delivered, up to 6 weeks after enrollment.

Secondary outcomes

  1. Antibiotics received by neonate

    Time frame: At time of chart review approximately 6 weeks after enrollment

  2. Maternal temperature

    Time frame: At the time of chart review approximately 6 weeks after enrollement

  3. Maternal white blood cell count

    Time frame: At the time of chart reivew approximately 6 weeks after enrollment

07

Study locations

1 site
  • Medical Faculty Associates
    Washington, District of Columbia 20037, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01180023
Lead sponsor
George Washington University
Responsible party
Jennifer Keller (Assistant Professor- OBGYN, George Washington University) — Principal investigator
First posted
Aug 11, 2010
Start date
Apr 2008
Primary completion
Apr 2011
Completion
Apr 2011
Last update
Feb 15, 2013

Study contacts

Jennifer M Keller, MD MPH
principal investigator · The George Washington University

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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