Randomized Control Trial between Two Hourly Oral Misoprostol and Propess for Induction of Labor

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000479707

Enrollment

200

Registered

2013-04-30

Start date

2012-11-19

Completion date

2013-12-30

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The research hypothesis is that more women for whom induction of labor is indicated will undergo vaginal delivery within 24 hours with 2 hourly treatment with 20 mcg oral misoprostol compared with 10 mg dinoprostone delivered via vaginal pessary.The primary objective is to compare the achievement of vaginal delivery within 24 hoursfollowing induction with static dose oral misoprostol and sustained-release vaginal dinoprostone.

Interventions

Group A: 20 mcg misoprostol orally every 2 hours A tablet (200 mcg) misoprostol will be dissolved in 200 mL water, producing a 1 mcg/mL solution. Achieving a uniform solution may be facilitated by crushing the tablet and/or using warm water to dissolve. Each 2 hourly oral dose will be provided as 20 mL of the misoprostol solution. Dosing will be continued until the subject achieves active labor (regular contractions occurring each 3 to 5 minutes, and lasting at least 60 seconds).

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

1. Singleton pregnancy for induction of labor 2. No contraindication to either drug 3. Bishop score <6 4. Documented nonreactive stress test (NST) 5. Written informed consent

Exclusion criteria

1. <34 weeks gestation 2. Severe pregnancy induced hypertension 3. Previous C/S or other uterine surgery 4. Parity 4 and more 5. Current uterine contractions

Outcome results