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Status unknownNCT02985086Updated Dec 13, 2016

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

An interventional study of Cefoxitin and oxytocin/misoprostol in Maternal Infection During Pregnancy (Diagnosis) and Neonatal Infection, sponsored by Hospital de Santa Maria, Portugal. Status unknown at 2 sites in Portugal. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-12-13.

Primary conditionnone(registry's first term: Disease)No conditionIs this wrong?Disease describes something many studies share rather than a condition a study is about. The study names no condition we can place it under, so it is not compared with other studies by condition.

Sponsored by Hospital de Santa Maria, Portugal · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2016), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
568
Allocation
Randomized
Sex
Female
01

Study summary

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.

Read the detailed description

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).

02

Conditions studied

  • Maternal Infection During Pregnancy (Diagnosis)
  • Neonatal Infection

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Keywords

  • term premature rupture of membranes, antibiotic prophylaxis, chorioamnionitis, endometritis, neonatal infection
03

In context

Lead sponsor

Hospital de Santa Maria, Portugal is the lead sponsor of 10 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • active labor, absence of GBS culture or indication for GBS antibiotic prophylaxis, to expectant management or to vaginal delivery
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
568 participants (estimated)

Study arms

  • Active comparator
    Immediate induction with antibiotic prophylaxis

    Immediate induction with antibiotic prophylaxis

    Drug: Cefoxitin · Drug: oxytocin/misoprostol

  • Active comparator
    Immediate induction without antibiotic prophylaxis

    Immediate induction without antibiotic prophylaxis

    Drug: oxytocin/misoprostol

  • Active comparator
    Delayed induction with antibiotic prophylaxis

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

    Drug: Cefoxitin · Drug: oxytocin/misoprostol

Interventions

06

What researchers measure

Primary outcomes

  1. Maternal and neonatal infection rate

    Time frame: intrapartum and immediate postpartum

07

Study locations

2 of 2 sites recruiting
  • Hospital Garcia de Orta, EPE
    Almada, Portugal
    Recruiting
  • Hospital de Santa Maria, CHLN, EPE
    Lisbon, Portugal
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2013, a primary completion of Jul 2018 and a completion of Jul 2018. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 5, 2016
First posted
Dec 7, 2016
Start
Jul 2013
Primary completionEst.
Jul 2018
CompletionEst.
Jul 2018
Last update
Dec 13, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Dec 13, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02985086
Lead sponsor
Hospital de Santa Maria, Portugal
Responsible party
Filipa Faria Vaz Passos (Principal Investigator, Hospital de Santa Maria, Portugal) — Principal investigator
First posted
Dec 7, 2016
Start date
Jul 2013
Primary completion
Jul 2018 (estimated)
Completion
Jul 2018 (estimated)
Last update
Dec 13, 2016

Study contacts

Filipa FV Passos, MD
Contact
filipafariavazpassos@gmail.com
00351966634530
Rita Silva, MD
Contact
r.i.t.a.i.m.s.i.l.v.a@gmail.com
00351963915366

Oversight

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

Not currently enrolling

This study is status unknown, as verified in Dec 2016. You cannot join it, but the record below documents what was studied.

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