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Clinical Trials/NCT01863797
NCT01863797CompletedNot Applicable

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

Karolinska Institutet2 sites in 1 country138 target enrollmentStarted: June 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
138
Locations
2
Primary Endpoint
The primary outcome was mode of delivery (caesarean sections and vaginal deliveries (spontaneous and instrumental))

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
16 Years to 45 Years (Child, Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

The primary outcome was mode of delivery (caesarean sections and vaginal deliveries (spontaneous and instrumental))

Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 3 days

Secondary Outcomes

  • Maternal outcome measure included experience of delivery(Experience of delivery was assessed two days after delivery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Elena Bräne

RNM

Karolinska Institutet

Study Sites (2)

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