Balloon catheter versus misoprostol for the induction of labor following pre-labor rupture of membranes at term

Not Applicable

Completed

• Conditions: Premature rupture of membranes with the onset of labor more than 24 hours following rupture, prolonged rupture of membranes at term with an unfavorable cervix; Pregnancy and Childbirth; Premature rupture of membranes with the onset of labor more than 24 hours following rupture

• Registration Number: ISRCTN10972090
• Lead Sponsor: Helsinki University Central Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-02-05
• Study Completion: 2023-12-31
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 180

Inclusion Criteria

1. Aged =18 years
2. Primiparous or multiparous women with singleton pregnancy
3. Gestational age =37 weeks (term)
4. Spontaneous rupture of membranes without the onset of labor within 18-48 h
5. Unfavorable cervix (Bishops score <6)
6. Cephalic presentation of fetus
7. No colonization of Group B Streptococcus on vaginal and rectal swab

Exclusion Criteria

1. Pre-term pre-labor rupture of membranes (<37 gestational weeks)
2. Clinical signs of infection (such as vaginitis, chorionamnionitis)
3. Active infection or carrier of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C
4. Type 1 diabetes
5. Group B Streptococcal colonization of vagina and/or rectum (detected by swab test)
6. Any acute condition, maternal or fetal, requiring the immediate delivery of the fetus
7. Intrauterine growth restriction
8. Macrosomia or weight estimation =4.5 kg
9. Fetus in any other presentation than cephalic (such as breech or transverse)
10. Previous caesarean section or any other uterotomy (such as myomectomy)
11. Insufficient understanding or language deficiency to comprehend the patient guide and consent form
12. Refusal of participation or refusal for signed consent

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Incidence of different modes of delivery (vaginal birth, assisted vaginal birth, or caesarean section), maternal infection, and newborn infection collected from patient records between hospital admission and discharge

Secondary Outcome Measures

Name	Time	Method
1. Maternal complications of delivery (such as retention of placenta, hemorrhage, birth canal tears, and intrapartum or postpartum infection) collected from patient records between hospital admission and discharge<br>2. Primary assessment of the newborn measured using Apgar score at 1 and 5 min after birth, and using umbilical vein pH and base excess, need for intubation, and need for NICU admission collected from patient records between hospital admission and discharge<br>3. Birth experience measured using the Childbirth Experience Questionnaire (CEQ2) completed within 1 month after delivery