PeRinatal Outcomes with ACTive versus expectant management of women with Pre-labor Rupture Of Membranes: a phase III, open-label, randomized controlled multicentric trial

Phase 1

• Conditions: 1400 Women with PROM at term and a GBS negative swab; MedDRA version: 20.0Level: PTClassification code 10073024Term: Preterm premature rupture of membranesSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2022-002480-30-IT
• Lead Sponsor: AZIENDA OSPEDALIERO-UNIVERSITARIA DI MODENA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-11-18
• Last Update Posted: 8 January 2024

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 1400

Inclusion Criteria

1. Gestational age = 37 weeks
2. Negative rectovaginal GBS swab
3. Absent/poor uterine contractile activity 6 h after PROM (0-2 contractions /10 min)
4. Cephalic presentation
5. Age =18 years of age at the time of randomization
6. Ability to provide an informed consent
7. Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 1400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Prematurity (<37 weeks)
2. GBS positive vagino-rectal swab or with an unknown swab
3. Multiple pregnancies
4. Previous cesarean section (CS)
5. Breech presentation, transverse lie or other indication for elective CS
6. Suspected clinic for intra-amniotic infection
7. Stained amniotic fluid
8. Alterations of the FHR
9. Unknown exact ROM time

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified