Trial on Early Induction Versus Expectant Management of Nulliparous Women With a Prolonged Latent Phase

Not Applicable

Completed

• Conditions: Nulliparous Women With Prolonged Latent Phase
• Interventions: Other: Early induction; Other: Expectant mamagement

• Registration Number: NCT01863797
• Lead Sponsor: Karolinska Institutet

Brief Summary

The purpose of the study was to compare early induction versus expectant management regarding outcome and experience of delivery in nulliparous women with a prolonged latent phase.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2013-05
• Study First Submitted: 2013-05-20
• Study First Submitted QC: 2013-05-23
• Last Update Submitted: 2013-05-23
• Study First Posted: 2013-05-29
• Last Update Posted: 2013-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 138

Inclusion Criteria

• generally healthy nulliparous women and normal pregnancies (in vitro-fertilisation included)
• with a singleton fetus in cephalic presentation,
• gestational age between 37+0 and 41+6,
• continuous contractions exceeding 18 hours impeding rest (women's report),
• a cervical dilation of less than four centimetres and intact membranes. Gestational age was confirmed by ultrasound in the first trimester.

Women had to be able to read, understand and speak Swedish.

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early induction	Early induction	Induction was performed if membranes were still intact and cervical dilation was less than four centimetres five hours after medication for therapeutic rest. For participants with an unripe cervix intravaginal prostaglandin E2 (PgE2, dinoproston) was used. A transcervical catheter (BARD) was inserted if this procedure was possible 19 and if cervical dilatation permitted, amniotomy was performed. The physician in charge performed all assessments and procedures except amniotomy. When the participants reached the active phase they were monitored according to the clinical guidelines.
expectant management	Expectant mamagement	The participants in the control group awaited spontaneous onset of labour as long as possible (expectant management). If contractions had ceased or subsided after the therapeutic rest women could be discharged from hospital, but were still included in the study. When reaching the active phase of labour women were monitored according to the clinical guidelines.

Primary Outcome Measures

Name	Time	Method
The primary outcome was mode of delivery (caesarean sections and vaginal deliveries (spontaneous and instrumental))	Participants will be followed for the duration of hospital stay, an expected average of 3 days

Secondary Outcome Measures

Name	Time	Method
Maternal outcome measure included experience of delivery	Experience of delivery was assessed two days after delivery	Wijma Delivery Experience Questionnaire - validated instrument. The 33 question questionnaire was filled in by the participance two days after delivery at postnatal care unit or at home.

Trial Locations

Locations (1)

Förlossningen, Danderyd Hospital; 🇸🇪 Stockholm, Sweden