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A Randomized Controlled Trial on Expectant versus Active Management with Sublingual Prostaglandin E-1 Analogue for Term Premature Rupture of the Fetal Membranes

A Randomized Controlled Trial on Expectant versus Active Management with Sublingual Prostaglandin E-1 Analogue for Term Premature Rupture of the Fetal Membranes

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR202206797734088
Enrollment
86
Registered
2022-06-10
Start date
2022-06-03
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Term Premature Rupture of Fetal Membranes

Interventions

Expectant management Management of term Premature Rupture of Fetal Membranes group
Active management of Term Premature Rupture of Fetal Membranes

Sponsors

The Principal investigator Dr Awkadigwe Fredrick Ikenna
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: i. Gestational age 37weeks plus zero day to 41 weeks plus 2 days ii. Singleton pregnancy iii. Age 2034 years iv. Adequate pelvis v. Vertex presentation vi. Cervical dilatation less than 4cm vii. Live baby with normal cardiotocography (CTG) readings and ultrasound finding

Exclusion criteria

Exclusion criteria: I. Age 34 years II. Gestational age41weeks plus 2 days III. Multiple pregnancy IV. Chorioamnionitis V. Medical disorders in pregnancy VI. Obstetric complications VII. Grand multipara VIII. Previous caesarean delivery IX. Meconium stained liquour X. Cephalopelvic disproportion XI. Malpresentation XII. Intrauterine fetal death XIII. Prolonged PROM XIV. Cervical dilatation up to 4cm XV. In vitro fertilization pregnancies XVI. Multiple vaginal examinations prior to presentation XVII. Cervical incompetence

Design outcomes

Primary

MeasureTime frame
The primary outcome measure was the final route of delivery.

Secondary

MeasureTime frame
The secondary outcomes were the PROM to Delivery Interval, Latency Period and Recruitment to Delivery Interval Delivery Complications like Post Partum haemorrhage, Contractility Patterns, Fetal and Perinatal Outcomes as exemplified by APGAR Scores asphyxia as a measure of presumed perinatal , NICU Admissions and Care, and the Length of the NICU Admission.

Countries

Nigeria

Contacts

Public ContactGeorge Eleje

Department of Obstetrics and Gynaecology Nnamdi Azikiwe University Teaching Hospital Nnewi

georgel21@yahoo.com+2348068117444

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Aug 9, 2026