The objective of this pilot study is to get a preliminary understanding of the amniotomy-to-delivery interval, patient experience and risks by awaiting spontaneous contractions after amniotomy. Simultaneously we*ll be able to evaluate the process of…
ID
Source
Brief title
Condition
- Pregnancy, labour, delivery and postpartum conditions
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Amniotomy to delivery interval.
Patient satisfaction.
Secondary outcome
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 <7 at 5 minutes
- Neonatal infection
Pilot evaluation
- The enrolment rate
- Rate and reason of violation of study protocol
Background summary
Common practice in induction of labour is to perform an amniotomy and start
with oxytocin infusion. Avoidance of oxytocin infusion in induction of labour
may result in higher patient satisfaction and prevention of side effects.
Especially in women with low or medium risk induction indications (such as
prolonged pregnancy (>41wks of pregnancy), mild hypertensive disorders,
diabetes or maternal request) the increase of labour duration is thought be
acceptable and advantages may be reached.
Study objective
The objective of this pilot study is to get a preliminary understanding of the
amniotomy-to-delivery interval, patient experience and risks by awaiting
spontaneous contractions after amniotomy. Simultaneously we*ll be able to
evaluate the process of randomizing the induction-method.
Study design
Pilot randomized controlled trial.
Intervention
Awaiting spontaneous contractions for 12 hours after amniotomy, compared to
standard care (immediate oxytocin infusion after amniotomy).
Study burden and risks
Labour may be prolonged due to awaiting spontaneous contractions, especially
for nulliparous women. Prolonged rupture of membranes (>18 hours) is a risk
factor for early onset group B streptococcal sepsis. There is a potential
increased risk of maternal infections. No increased risk of neonatal adverse
events is expected.
Jan Tooropstraat 164
Amsterdam 1061AE
NL
Jan Tooropstraat 164
Amsterdam 1061AE
NL
Listed location countries
Age
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
- Previous caesarean section
- Fetal distress prior to induction
- Maternal fever prior to induction
- Contra-indication for oxytocin
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL60566.100.17 |