Trial Outcomes & Findings for Foley OR MisO for the Management of Induction (NCT NCT01916681)

NCT ID: NCT01916681

Last Updated: 2017-05-18

Results Overview

Amount of hours that pass between the start of the induction to delivery.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 491 participants
• Primary outcome timeframe: Hours between start of induction to delivery
• Results posted on: 2017-05-18

Participant Flow

Participant milestones

Measure	Cervical Foley & Misoprostol Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor. Cervical Foley \& Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient.	Misoprostol Only Patients randomized to this arm will receive misoprostol to induce their labor. Misoprostol Alone: Misoprostol will be used alone to induce the patient	Cervical Foley Alone Patients randomized to this arm will receive a cervical foley to induce their labor. Cervical Foley Alone: A cervical foley alone will be used to induce the patient	Cervical Foley & Pitocin Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor. Cervical Foley \& Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient
Overall Study STARTED	123	120	123	125
Overall Study COMPLETED	123	120	123	125
Overall Study NOT COMPLETED	0	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Foley OR MisO for the Management of Induction

Baseline characteristics by cohort

Measure	Cervical Foley & Misoprostol n=123 Participants Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor. Cervical Foley \& Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient.	Misoprostol Only n=120 Participants Patients randomized to this arm will receive misoprostol to induce their labor. Misoprostol Alone: Misoprostol will be used alone to induce the patient	Cervical Foley Alone n=123 Participants Patients randomized to this arm will receive a cervical foley to induce their labor. Cervical Foley Alone: A cervical foley alone will be used to induce the patient	Cervical Foley & Pitocin n=125 Participants Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor. Cervical Foley \& Pitocin: A cervical foley combined with pitocin will be used to induce the patient	Total n=491 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	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	123 Participants n=5 Participants	120 Participants n=7 Participants	123 Participants n=5 Participants	125 Participants n=4 Participants	491 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Continuous	28 Years n=5 Participants	26.7 Years n=7 Participants	27.3 Years n=5 Participants	26.5 Years n=4 Participants	27 Years n=21 Participants
Sex: Female, Male Female	123 Participants n=5 Participants	120 Participants n=7 Participants	123 Participants n=5 Participants	125 Participants n=4 Participants	491 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Region of Enrollment United States	123 participants n=5 Participants	120 participants n=7 Participants	123 participants n=5 Participants	125 participants n=4 Participants	491 participants n=21 Participants

PRIMARY outcome

Timeframe: Hours between start of induction to delivery

Amount of hours that pass between the start of the induction to delivery.

Outcome measures

Measure	Cervical Foley & Misoprostol n=123 Participants Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor. Cervical Foley \& Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient.	Misoprostol Only n=120 Participants Patients randomized to this arm will receive misoprostol to induce their labor. Misoprostol Alone: Misoprostol will be used alone to induce the patient	Cervical Foley Alone n=123 Participants Patients randomized to this arm will receive a cervical foley to induce their labor. Cervical Foley Alone: A cervical foley alone will be used to induce the patient	Cervical Foley & Pitocin n=125 Participants Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor. Cervical Foley \& Pitocin: A cervical foley combined with pitocin will be used to induce the patient
Time to Delivery	13.1 Hours Interval 9.1 to 18.3	17.6 Hours Interval 11.9 to 26.7	17.7 Hours Interval 12.6 to 24.9	14.5 Hours Interval 9.3 to 20.0

PRIMARY outcome

Timeframe: Days between admit to hospital and discharge

Total maternal length of stay as defined as days from the day the induction began to the day of discharge

Outcome measures

Measure	Cervical Foley & Misoprostol n=123 Participants Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor. Cervical Foley \& Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient.	Misoprostol Only n=120 Participants Patients randomized to this arm will receive misoprostol to induce their labor. Misoprostol Alone: Misoprostol will be used alone to induce the patient	Cervical Foley Alone n=123 Participants Patients randomized to this arm will receive a cervical foley to induce their labor. Cervical Foley Alone: A cervical foley alone will be used to induce the patient	Cervical Foley & Pitocin n=125 Participants Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor. Cervical Foley \& Pitocin: A cervical foley combined with pitocin will be used to induce the patient
Length of Stay	3 Days Interval 3.0 to 4.0	3 Days Interval 3.0 to 4.0	3 Days Interval 3.0 to 4.0	3 Days Interval 3.0 to 4.0

PRIMARY outcome

Timeframe: enrollment through neonatal discharge

Outcome measures

Measure	Cervical Foley & Misoprostol n=123 Participants Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor. Cervical Foley \& Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient.	Misoprostol Only n=120 Participants Patients randomized to this arm will receive misoprostol to induce their labor. Misoprostol Alone: Misoprostol will be used alone to induce the patient	Cervical Foley Alone n=123 Participants Patients randomized to this arm will receive a cervical foley to induce their labor. Cervical Foley Alone: A cervical foley alone will be used to induce the patient	Cervical Foley & Pitocin n=125 Participants Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor. Cervical Foley \& Pitocin: A cervical foley combined with pitocin will be used to induce the patient
Severe RDS	0 participants	1 participants	2 participants	0 participants

SECONDARY outcome

Timeframe: Start of induction to delivery

Cesarean Delivery

Outcome measures

Measure	Cervical Foley & Misoprostol n=123 Participants Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor. Cervical Foley \& Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient.	Misoprostol Only n=120 Participants Patients randomized to this arm will receive misoprostol to induce their labor. Misoprostol Alone: Misoprostol will be used alone to induce the patient	Cervical Foley Alone n=123 Participants Patients randomized to this arm will receive a cervical foley to induce their labor. Cervical Foley Alone: A cervical foley alone will be used to induce the patient	Cervical Foley & Pitocin n=125 Participants Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor. Cervical Foley \& Pitocin: A cervical foley combined with pitocin will be used to induce the patient
Mode of Delivery	34 participants	29 participants	35 participants	38 participants

SECONDARY outcome

Timeframe: Start of induction to active labor

Outcome measures

Measure	Cervical Foley & Misoprostol n=123 Participants Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor. Cervical Foley \& Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient.	Misoprostol Only n=120 Participants Patients randomized to this arm will receive misoprostol to induce their labor. Misoprostol Alone: Misoprostol will be used alone to induce the patient	Cervical Foley Alone n=123 Participants Patients randomized to this arm will receive a cervical foley to induce their labor. Cervical Foley Alone: A cervical foley alone will be used to induce the patient	Cervical Foley & Pitocin n=125 Participants Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor. Cervical Foley \& Pitocin: A cervical foley combined with pitocin will be used to induce the patient
Time to Active Labor	7.4 Hours Interval 4.4 to 10.7	13.3 Hours Interval 9.1 to 22.4	11.0 Hours Interval 7.9 to 14.9	8.1 Hours Interval 5.3 to 11.2

SECONDARY outcome

Timeframe: During delivery

Outcome measures

Measure	Cervical Foley & Misoprostol n=123 Participants Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor. Cervical Foley \& Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient.	Misoprostol Only n=120 Participants Patients randomized to this arm will receive misoprostol to induce their labor. Misoprostol Alone: Misoprostol will be used alone to induce the patient	Cervical Foley Alone n=123 Participants Patients randomized to this arm will receive a cervical foley to induce their labor. Cervical Foley Alone: A cervical foley alone will be used to induce the patient	Cervical Foley & Pitocin n=125 Participants Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor. Cervical Foley \& Pitocin: A cervical foley combined with pitocin will be used to induce the patient
Regional Anesthesia	114 participants	111 participants	114 participants	121 participants

SECONDARY outcome

Timeframe: Enrollment through deischarge

Outcome measures

Measure	Cervical Foley & Misoprostol n=123 Participants Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor. Cervical Foley \& Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient.	Misoprostol Only n=120 Participants Patients randomized to this arm will receive misoprostol to induce their labor. Misoprostol Alone: Misoprostol will be used alone to induce the patient	Cervical Foley Alone n=123 Participants Patients randomized to this arm will receive a cervical foley to induce their labor. Cervical Foley Alone: A cervical foley alone will be used to induce the patient	Cervical Foley & Pitocin n=125 Participants Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor. Cervical Foley \& Pitocin: A cervical foley combined with pitocin will be used to induce the patient
Chorioamnionitis	15 participants	9 participants	17 participants	20 participants

SECONDARY outcome

Timeframe: Enrollment through discharge

Outcome measures

Measure	Cervical Foley & Misoprostol n=123 Participants Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor. Cervical Foley \& Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient.	Misoprostol Only n=120 Participants Patients randomized to this arm will receive misoprostol to induce their labor. Misoprostol Alone: Misoprostol will be used alone to induce the patient	Cervical Foley Alone n=123 Participants Patients randomized to this arm will receive a cervical foley to induce their labor. Cervical Foley Alone: A cervical foley alone will be used to induce the patient	Cervical Foley & Pitocin n=125 Participants Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor. Cervical Foley \& Pitocin: A cervical foley combined with pitocin will be used to induce the patient
Maternal Morbidity	5 participants	8 participants	13 participants	10 participants

Adverse Events

Cervical Foley & Misoprostol

Serious events: 0 serious events

Other events: 30 other events

Deaths: 0 deaths

Misoprostol Only

Serious events: 0 serious events

Other events: 33 other events

Deaths: 0 deaths

Cervical Foley Alone

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Cervical Foley & Pitocin

Serious events: 0 serious events

Other events: 46 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Cervical Foley & Misoprostol n=123 participants at risk Patients randomized to this arm will receive a cervical foley and misoprostol to induce their labor. Cervical Foley \& Misoprostol: A cervical foley combined with misoprostol will be used to induce the patient.	Misoprostol Only n=120 participants at risk Patients randomized to this arm will receive misoprostol to induce their labor. Misoprostol Alone: Misoprostol will be used alone to induce the patient	Cervical Foley Alone n=123 participants at risk Patients randomized to this arm will receive a cervical foley to induce their labor. Cervical Foley Alone: A cervical foley alone will be used to induce the patient	Cervical Foley & Pitocin n=125 participants at risk Patients randomized to this arm will receive a cervical foley and pitocin to induce their labor. Cervical Foley \& Oxytocin: A cervical foley combined with oxytocin will be used to induce the patient
Pregnancy, puerperium and perinatal conditions Chorioamnionitis	12.2% 15/123 • Number of events 15 • Up to 6 weeks postpartum.	7.5% 9/120 • Number of events 9 • Up to 6 weeks postpartum.	13.8% 17/123 • Number of events 17 • Up to 6 weeks postpartum.	16.0% 20/125 • Number of events 20 • Up to 6 weeks postpartum.
Pregnancy, puerperium and perinatal conditions Endometritis	0.00% 0/123 • Up to 6 weeks postpartum.	0.83% 1/120 • Number of events 1 • Up to 6 weeks postpartum.	0.00% 0/123 • Up to 6 weeks postpartum.	0.00% 0/125 • Up to 6 weeks postpartum.
Pregnancy, puerperium and perinatal conditions Wound Infection	0.81% 1/123 • Number of events 1 • Up to 6 weeks postpartum.	0.83% 1/120 • Number of events 1 • Up to 6 weeks postpartum.	0.81% 1/123 • Number of events 1 • Up to 6 weeks postpartum.	2.4% 3/125 • Number of events 3 • Up to 6 weeks postpartum.
Pregnancy, puerperium and perinatal conditions Venous Thromboembolism	0.00% 0/123 • Up to 6 weeks postpartum.	0.00% 0/120 • Up to 6 weeks postpartum.	0.00% 0/123 • Up to 6 weeks postpartum.	0.00% 0/125 • Up to 6 weeks postpartum.
Pregnancy, puerperium and perinatal conditions Maternal blood transfusion	0.81% 1/123 • Number of events 1 • Up to 6 weeks postpartum.	1.7% 2/120 • Number of events 2 • Up to 6 weeks postpartum.	4.1% 5/123 • Number of events 5 • Up to 6 weeks postpartum.	3.2% 4/125 • Number of events 4 • Up to 6 weeks postpartum.
Pregnancy, puerperium and perinatal conditions Postpartum readmission	1.6% 2/123 • Number of events 2 • Up to 6 weeks postpartum.	1.7% 2/120 • Number of events 2 • Up to 6 weeks postpartum.	2.4% 3/123 • Number of events 3 • Up to 6 weeks postpartum.	5.6% 7/125 • Number of events 7 • Up to 6 weeks postpartum.
Pregnancy, puerperium and perinatal conditions NICU admission	8.1% 10/123 • Number of events 10 • Up to 6 weeks postpartum.	12.5% 15/120 • Number of events 15 • Up to 6 weeks postpartum.	13.8% 17/123 • Number of events 17 • Up to 6 weeks postpartum.	8.8% 11/125 • Number of events 11 • Up to 6 weeks postpartum.
Pregnancy, puerperium and perinatal conditions Neonatal blood transfusion	0.00% 0/123 • Up to 6 weeks postpartum.	0.00% 0/120 • Up to 6 weeks postpartum.	0.00% 0/123 • Up to 6 weeks postpartum.	0.00% 0/125 • Up to 6 weeks postpartum.
Pregnancy, puerperium and perinatal conditions Hypoxic-ischemic encephalopathy	0.00% 0/123 • Up to 6 weeks postpartum.	0.00% 0/120 • Up to 6 weeks postpartum.	0.00% 0/123 • Up to 6 weeks postpartum.	0.00% 0/125 • Up to 6 weeks postpartum.
Pregnancy, puerperium and perinatal conditions Intraventricular hemorrhage Grade 3 or 4	0.00% 0/123 • Up to 6 weeks postpartum.	0.00% 0/120 • Up to 6 weeks postpartum.	0.00% 0/123 • Up to 6 weeks postpartum.	0.00% 0/125 • Up to 6 weeks postpartum.
Pregnancy, puerperium and perinatal conditions Severe respiratory distress	0.00% 0/123 • Up to 6 weeks postpartum.	0.83% 1/120 • Number of events 1 • Up to 6 weeks postpartum.	1.6% 2/123 • Number of events 2 • Up to 6 weeks postpartum.	0.00% 0/125 • Up to 6 weeks postpartum.
Pregnancy, puerperium and perinatal conditions Necrotizing enterocolitis or rule out NEC	0.00% 0/123 • Up to 6 weeks postpartum.	0.00% 0/120 • Up to 6 weeks postpartum.	0.00% 0/123 • Up to 6 weeks postpartum.	0.00% 0/125 • Up to 6 weeks postpartum.
Pregnancy, puerperium and perinatal conditions Culture proven neonatal sepsis	0.00% 0/123 • Up to 6 weeks postpartum.	0.00% 0/120 • Up to 6 weeks postpartum.	0.00% 0/123 • Up to 6 weeks postpartum.	0.00% 0/125 • Up to 6 weeks postpartum.
Pregnancy, puerperium and perinatal conditions Presumed Sepsis	0.81% 1/123 • Number of events 1 • Up to 6 weeks postpartum.	1.7% 2/120 • Number of events 2 • Up to 6 weeks postpartum.	0.81% 1/123 • Number of events 1 • Up to 6 weeks postpartum.	0.80% 1/125 • Number of events 1 • Up to 6 weeks postpartum.

Additional Information

Dr. Lisa Levine

University of Pennsylvania

Phone: 2156626913

Email: lisa.levine@uphs.upenn.edu

Results disclosure agreements

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