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

Karolinska Institute

Status: Completed

Conditions: Nulliparous Women With Prolonged Latent Phase

Treatments: Other: Early induction; Other: Expectant mamagement

Study type: Interventional

Funder types: Other

Identifiers

NCT01863797

EPN 2007/65-31/2

2007/65-31/2 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: Female

Ages: 16 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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138 participants in 2 patient groups

Early induction

Active Comparator group

Description:

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.

Treatment:

Other: Early induction

expectant management

Experimental group

Description:

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.

Treatment:

Other: Expectant mamagement