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NCT01180023 · ClinicalTrials.gov registry record · NA
Membrane Sweeping in Group B Streptococcus (GBS) Positive Patients
A NA study, sponsored by George Washington University.
- Completed
- Registry status
- NA
- Development phase
- 120
- Enrollment target
NCT01180023 is a NA study that has completed, run by George Washington University. The registered enrollment target is 120 participants.
The verdict
NCT01180023, a NA study, has completed, sponsored by George Washington University.
- COMPLETED
- Registry status
- NA
- Development phase
- 120 participants
- Enrollment target
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
Interventions
- PROCEDURE Sweeping
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2008-04 |
| Est. Completion | 2011-04 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01180023
The ClinicalTrials.gov registry entry for NCT01180023 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 120 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is George Washington University, which has 133 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Sweeping is the first listed.
NCT01180023 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01180023 about?
NCT01180023 is a clinical study titled "Membrane Sweeping in Group B Streptococcus (GBS) Positive Patients". 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 me...
What is the current status of trial NCT01180023?
This trial is currently completed. It is a NA study. The enrollment target is 120 participants. The study started on 2008-04. Estimated completion is 2011-04.
What interventions are being tested in trial NCT01180023?
The interventions under investigation include: Sweeping (PROCEDURE).
Who is sponsoring clinical trial NCT01180023?
This trial is sponsored by George Washington University, which has 133 total clinical trials registered on ClinicalTrials.gov.
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