PeRinatal Outcomes With ACTive Versus Expectant Management of Women With Pre-labor Rupture Of Membranes
NCT ID: NCT05958953
Last Updated: 2023-07-25
Study Results
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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NOT_YET_RECRUITING
PHASE3
1400 participants
INTERVENTIONAL
2023-09-30
2025-11-12
Brief Summary
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In PeRinatal Outcomes With ACTive Versus Expectant Management of Women With Pre-labor Rupture Of Membranes (PROACTIVE PROM) on admission, PROM will be diagnosed. After 6 hours from the rupture of membranes, the woman will then be assessed for eligibility. A 1:1 randomization will follow within two hours (6-8 hours from PROM) in two distinct arms: 1) Expectant management 2) Active menagement (early IOL within 8 hours of rupture of membranes).
The first objective of this study is to evaluate whether active management of women with PROM (early induction) reduces the newborn need of respiratory support.
The secondary objectives of this study are related to the safety of the active management assessed through the rate of stillbirths, the onset of infections in both mother and fetus and the length of hospitalization of the dyads. Moreover, another objective is to reduce the use of antibiotic treatments (ATB) in both mothers and newborns.
The rationale of this study is that reducing the time between the PROM and delivery through an early IOL will reduce the adverse maternal and neonatal outcomes.
The hypothesis underneath this trial comes from a preliminary retrospective cohort study conducted in Modena, which included 2689 mother-neonates dyads from singleton pregnant women at term. In deliveries of ROM \>24 hours significantly more neonates required ventilatory support than those born within 24 hours, although no significant differences were found regarding overt infections. According to the Cochrane database, expectant management of PROM is associated with maternal and fetal infectious complications and subsequent increased risk of maternal and neonatal morbidity together with an increased risk of ATB use. The increase of infectious risk is proportional to the time elapsed since the rupture of the membranes (ROM) and birth. However, unpublished data from our group suggest that respiratory distress requiring interventions may be frequently caused by intrinsic inflammatory-related effects of prolonged ROM rather than infection; this is suggested by an increase of C-reactive protein levels in neonates with mild respiratory signs untreated with antibiotics.
In addition, in a survey performed in our country expectant management increased intrapartum antibiotic prophylaxis (IAP), although not strictly indicated by the most current guidelines.
On the light of these data, it appears reasonable to promote induction of labor, to prevent complication caused not only by the infectious risk mentioned above, but also respiratory distress, probably associated to a neonatal maladaptation, in non-infectious newborns.
On the other hand, it should also be considered that 75% of women enter labor spontaneously within 24 hours from PROM and induction of labor (IOL) might not be needed in such cases.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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active management
early IOL within 8 hours of rupture of membranes. Center-specific IOL protocols will be used.
Induction of Labor IoL
Center-specific IOL protocols, based on international guidelines, will be used.
Expectant management
monitoring until 24 hours from rupture of membranes, with subsequent induction of labor (IOL).
No interventions assigned to this group
Interventions
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Induction of Labor IoL
Center-specific IOL protocols, based on international guidelines, will be used.
Eligibility Criteria
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Inclusion Criteria
2. Gestational age ≥ 37 weeks
3. Negative rectovaginal GBS swab
4. Absent/poor uterine contractile activity 6 h after PROM (0-2 contractions /10 min)
5. Cephalic presentation
6. Ability to provide an informed consent
7. Signed informed consent
Exclusion Criteria
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 (According to the Triple I criteria)
7. Stained amniotic fluid
8. Alterations of the FHR
9. Unknown exact ROM time
10. Known hypersensitivity to drugs for IOL or their excipients
11. Presence of unknown vaginal bleeding
12. Presence of maternal kidney disease (GFR \<15 ml/min/1,73 m2).
13. Every condition contraindicating vaginal delivery
18 Years
FEMALE
No
Sponsors
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University of Modena and Reggio Emilia
OTHER
Responsible Party
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Prof. Fabio Facchinetti
Full professor of Obstetrics and Gynecology Chairmen Unit of Obstetrics and Gynecology
Locations
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AUO Policlinico di Modena
Modena, , Italy
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2022-002480-30
Identifier Type: -
Identifier Source: org_study_id
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