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

Study Overview
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Brief Summary
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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
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Nulliparous Women With Prolonged Latent Phase

Intervention / Treatment
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* Other: Early induction
* Other: Expectant mamagement


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Early induction<br>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. | Other: Early induction<br> <br> |
| Experimental: expectant management<br>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. | Other: Expectant mamagement<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal outcome measure included experience of 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. | Experience of delivery was assessed two days after delivery |