Trial Outcomes & Findings for Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon (NCT NCT01139801)

NCT ID: NCT01139801

Last Updated: 2018-08-24

Results Overview

To assess effectiveness of misoprostol used in conjunction with Foley balloon versus the standard oxytocin regimen in regards to induction times

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 50 participants
• Primary outcome timeframe: 24 hrs
• Results posted on: 2018-08-24

Participant Flow

Participant milestones

Measure	Oxytocin Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.	Misoprostol Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
Overall Study STARTED	25	25
Overall Study COMPLETED	25	25
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon

Baseline characteristics by cohort

Measure	Oxytocin n=25 Participants Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.	Misoprostol n=25 Participants Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement	Total n=50 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	25 Participants n=5 Participants	25 Participants n=7 Participants	50 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hrs

Population: Patients requiring caesarean section excluded from analysis.

To assess effectiveness of misoprostol used in conjunction with Foley balloon versus the standard oxytocin regimen in regards to induction times

Outcome measures

Measure	Oxytocin n=16 Participants Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.	Misoprostol n=17 Participants Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
Rate of Induction To Delivery	732.19 minutes Standard Deviation 236.99	944.35 minutes Standard Deviation 317.78

SECONDARY outcome

Timeframe: 24 hrs

To assess for differences in delivery routes

Outcome measures

Measure	Oxytocin n=25 Participants Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.	Misoprostol n=25 Participants Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
Delivery Route Vagnial Delivery	16 Participants	17 Participants
Delivery Route Cesearean	9 Participants	8 Participants

Adverse Events

Oxytocin

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Misoprostol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jane Sewell

Aultman Health Foundation

Phone: 330-363-6793

Email: Jane.Sewell@aultman.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place