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

NCT ID: NCT01863797

Last Updated: 2013-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-06-30
• Study Completion Date: 2012-05-31

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.

Conditions

Nulliparous Women With Prolonged Latent Phase

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Early induction

Intervention Type: OTHER

expectant management

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.

Group Type: EXPERIMENTAL

Expectant mamagement

Intervention Type: OTHER

Interventions

Early induction

Intervention Type: OTHER

Expectant mamagement

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Karolinska Institutet

OTHER

Sponsor Role: lead

Responsible Party

Elena Bräne

RNM

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Förlossningen, Danderyd Hospital

Stockholm, Stockholm County, Sweden

Countries

Sweden

Other Identifiers

2007/65-31/2

Identifier Type: OTHER

Identifier Source: secondary_id

EPN 2007/65-31/2

Identifier Type: -

Identifier Source: org_study_id