A prospective comparative trial of Dilapan-S compared with Propess for induction of labor at 41+ weeks in nulliparous pregnancy

Not Applicable

Completed

• Conditions: Obstetrics: induction of labor; Pregnancy and Childbirth

• Registration Number: ISRCTN11067866
• Lead Sponsor: ational Maternity Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-14
• Last Update Posted: 21 August 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

1. Pregnant women in their first pregnancy (nulliparous women)
2. Adequate English to understand the purpose of the study
3. Scheduled for induction of labor for post-dates (=41 weeks gestation)
4. Unfavorable cervix defined as Bishops Score =6
5. Not suitable for artificial rupture of membranes (ARM)

Exclusion Criteria

1. Any pre-existing medical condition or medical condition of pregnancy
2. Pathological CTG prior to induction
3. Oligohydramnios on post-dates scan
4. 2 or more LLETZ treatments
5. Maternal age <18 years old or >40 years old
6. Body mass index =30kg/m2
7. Women with a closed cervix, insertion was not possible and so were unable to receive Dilapan-S

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Compliance with study protocol, quantified as the proportion of women who agreed to study participation and who completed the trial protocol of insertion of Dilapan-S. This occurred at time of insertion of the product<br>2. Safety: Maternal infection defined as maternal temperature greater than 38°C, endometritis, chorioamnionitis or antibiotic usage following study allocation until delivery of baby<br>3. Safety: Maternal hyperstimulation defined as > 7 contractions in 15 minutes at any time following study allocation until delivery of baby<br>4. Safety: Neonatal infection defined as fever, suspected or proven sepsis, or need for antibiotic use in the first 72 hours of life<br>5. Safety: Neonatal Apgar scores at 1 and 5 minutes of life