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Immediate Versus Delayed Induction in Term-PROM Using or Not Antibiotic Prophylaxis

NCT ID: NCT02985086

Last Updated: 2016-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

568 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2018-07-31

Brief Summary

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The primary aim of this study is to determine if antibiotics combined with immediate induction can significantly reduce the rate of maternal and neonatal infection compared with immediate induction alone in women presenting with PROM later than the 37+0 weeks of gestation. The secondary aim is to compare the rates of infection between immediate and delayed induction in women submitted to antibiotic prophylaxis.

Detailed Description

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In a randomized controlled non-blind trial, low-risk women with singleton term pregnancies and a negative Group B Streptococcus culture presenting with PROM are randomly assigned to group A (immediate induction with antibiotic prophylaxis), group B (immediate induction without antibiotic prophylaxis) or group C (delayed induction with antibiotic prophylaxis).

Conditions

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Maternal Infection During Pregnancy (Diagnosis) Neonatal Infection

Keywords

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term premature rupture of membranes, antibiotic prophylaxis, chorioamnionitis, endometritis, neonatal infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Immediate induction with antibiotic prophylaxis

Immediate induction with antibiotic prophylaxis

Group Type ACTIVE_COMPARATOR

Cefoxitin

Intervention Type DRUG

oxytocin/misoprostol

Intervention Type DRUG

Immediate induction without antibiotic prophylaxis

Immediate induction without antibiotic prophylaxis

Group Type ACTIVE_COMPARATOR

oxytocin/misoprostol

Intervention Type DRUG

Delayed induction with antibiotic prophylaxis

Delayed induction (\>= 12 hours after PROM) with antibiotic prophylaxis

Group Type ACTIVE_COMPARATOR

Cefoxitin

Intervention Type DRUG

oxytocin/misoprostol

Intervention Type DRUG

Interventions

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Cefoxitin

Intervention Type DRUG

oxytocin/misoprostol

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* term (≥ 37+0 weeks) singleton pregnancy, a vertex presentation, ruptured membranes for less than 12 hours and a negative Group B Streptococcus (GBS) culture performed between 35 and 37 weeks.

Exclusion Criteria

* active labor, absence of GBS culture or indication for GBS antibiotic prophylaxis, contraindication to expectant management or to vaginal delivery
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hospital de Santa Maria, Portugal

OTHER

Sponsor Role lead

Responsible Party

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Filipa Faria Vaz Passos

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Hospital Garcia de Orta, EPE

Almada, , Portugal

Site Status RECRUITING

Hospital de Santa Maria, CHLN, EPE

Lisbon, , Portugal

Site Status RECRUITING

Countries

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Portugal

Central Contacts

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Filipa FV Passos, MD

Role: CONTACT

Phone: 00351966634530

Email: [email protected]

Rita Silva, MD

Role: CONTACT

Phone: 00351963915366

Email: [email protected]

Other Identifiers

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SantaMariaGarciadeOrtaPortugal

Identifier Type: -

Identifier Source: org_study_id