A pilot randomized controlled trial of delayed versus immediate oxytocin infusion after amniotomy for induction of labour.

A pilot randomized controlled trial of delayed versus immediate oxytocin infusion after amniotomy for induction of labour. - DEAL-pilot study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON45440

Enrollment

180

Registered

2018-01-22

Start date

2017-11-05

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

augmentation of labour Induction

Interventions

Awaiting spontaneous contractions for 12 hours after amniotomy, compared to standard care (immediate oxytocin infusion after amniotomy).

Amniotomy

Induction

Labour

Oxytocin

Eligibility

Age

18 Years to 64 Years

Inclusion criteria

Inclusion criteria: - Due for induction of labour for the following maternal or fetal indications: o prolonged pregnancy (>41wks of pregnancy) o mild hypertensive disorders o diabetes o expected macrosomia o maternal request. - Term pregnancy (37-42 weeks of pregnancy) - Singleton pregnancy - Cephalic presentation of the fetus - Viable fetus - Favourable cervix (bishop score >5) and intact membranes - >= 18 years old - Sufficient command of the Dutch or English language

Exclusion criteria

Exclusion criteria: - Previous caesarean section - Fetal distress prior to induction - Maternal fever prior to induction - Contra-indication for oxytocin

Design outcomes

Primary

Measure	Time frame
Amniotomy to delivery interval. Patient satisfaction.	—

Secondary

Measure	Time frame
Process of delivery: - Amniotomy-to-oxytocin interval - Meconium stained fluid - Use of pain relief - Intrapartum fever - CTG FIGO-classification - Micro-blood-examination - Uterine hyperstimulation Outcome of delivery: - Total oxytocin augmentation time - Total oxytocin dose - Highest oxytocin dose - Mode of delivery - Haemorrhagia post partum - Apgarscore	—

Countries

The Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)