Trial Outcomes & Findings for Ripening Interventions: Prostaglandins vs EASI Catheter (NCT NCT00383942)

Results Overview

The number of women undergoing cesarean section will be compared between the misoprostol arm and EASI arm. The primary hypothesis is that the odds of receiving a cesarean section is lower among patients assigned to EASI when compared to patients who receive misoprostol.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

80 participants

Primary outcome timeframe

At time of delivery

Results posted on

2017-03-13

Participant Flow

Recruitment for the trial opened at Loyola University Medical Center (Maywood, IL) on 08/31/2006 and closed on 06/05/2008.

There are no pre-assignment details

Participant milestones

Participant milestones
Measure	Misoprostol Patients randomized to this arm receive 25 micrograms of misoprostol every 4 hours.	EASI Patients randomized to this arm receive an extra amniotic saline infusion via catheter that is placed in the uterus
Overall Study STARTED	40	40
Overall Study COMPLETED	40	40
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ripening Interventions: Prostaglandins vs EASI Catheter

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Misoprostol n=40 Participants Patients randomized to this arm receive 25 micrograms of misoprostol every 4 hours.	EASI n=40 Participants Patients randomized to this arm receive extra amniotic saline infusion via a catheter that is placed in the uterus	Total n=80 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	40 Participants n=5 Participants	40 Participants n=7 Participants	80 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	40 Participants n=5 Participants	40 Participants n=7 Participants	80 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: At time of delivery

Population: No participants are included in this analysis because the trial was terminated prematurely.

The number of women undergoing cesarean section will be compared between the misoprostol arm and EASI arm. The primary hypothesis is that the odds of receiving a cesarean section is lower among patients assigned to EASI when compared to patients who receive misoprostol.

Outcome measures

Outcome measures
Measure	Misoprostol Patients randomized to this arm receive 25 micrograms of misoprostol every 4 hours.	EASI Patients randomized to this arm recieve extra amniotic saline infusion (EASI) via a catheter that is placed in the uterus
Proportion of Women Undergoing Cesarean Section for Fetal Intolerance of Labor	0	0

Adverse Events

Misoprostol

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

EASI

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Misoprostol n=40 participants at risk Patients assigned to this arm received 25 micrograms of misoprostol every 4 hours	EASI n=40 participants at risk Patients assigned to this arm received extra amniotic saline infusion via a catheter that is placed in the uterus
Pregnancy, puerperium and perinatal conditions Pre-eclampsia	0.00% 0/40 • Adverse event data was collected for 1 year, 9 months.	2.5% 1/40 • Number of events 1 • Adverse event data was collected for 1 year, 9 months.

Additional Information

Scott Graziano, M.D.

Loyola University

Phone: 708-216-6288

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place