Trial · NCT01916681

Foley OR MisO for the Management of Induction

NCT01916681, Not applicable, Completed, University of Pennsylvania; results first posted 2016-12-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Foley OR MisO for the Management of Induction. Trials, record NCT01916681. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01916681

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Foley OR MisO for the Management of Induction
NCT number: NCT01916681
Status: Completed
Phases: Not applicable
Enrollment: 491 participants, actual
Lead sponsor: University of Pennsylvania
Conditions: Delivery; Prolonged
Interventions: Cervical Foley & Misoprostol, Misoprostol Alone, Cervical Foley Alone, Cervical Foley & Pitocin
First posted: 2013-08-06
Last updated: 2017-05-18
Results first posted: 2016-12-21

Source ClinicalTrials.gov

Registered outcomes8

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Time to Delivery	Hours between start of induction to delivery	Amount of hours that pass between the start of the induction to delivery.
Primary	Length of Stay	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
Primary	Severe RDS	enrollment through neonatal discharge
Secondary	Mode of Delivery	Start of induction to delivery	Cesarean Delivery
Secondary	Time to Active Labor	Start of induction to active labor
Secondary	Regional Anesthesia	During delivery
Secondary	Chorioamnionitis	Enrollment through deischarge
Secondary	Maternal Morbidity	Enrollment through discharge

Source ClinicalTrials.gov

Outcomes8

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Time to Delivery	Hours between start of induction to delivery	Hours	MEDIAN
PRIMARY	Length of Stay	Days between admit to hospital and discharge	Days	MEDIAN
PRIMARY	Severe RDS	enrollment through neonatal discharge	participants	NUMBER
SECONDARY	Mode of Delivery	Start of induction to delivery	participants	NUMBER
SECONDARY	Time to Active Labor	Start of induction to active labor	Hours	MEDIAN
SECONDARY	Regional Anesthesia	During delivery	participants	NUMBER
SECONDARY	Chorioamnionitis	Enrollment through deischarge	participants	NUMBER
SECONDARY	Maternal Morbidity	Enrollment through discharge	participants	NUMBER

Source ClinicalTrials.gov

Results by group32

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Time to Delivery	Cervical Foley & Misoprostol	13.1	Inter-Quartile Range 9.1 to 18.3	Hours
Time to Delivery	Misoprostol Only	17.6	Inter-Quartile Range 11.9 to 26.7	Hours
Time to Delivery	Cervical Foley Alone	17.7	Inter-Quartile Range 12.6 to 24.9	Hours
Time to Delivery	Cervical Foley & Pitocin	14.5	Inter-Quartile Range 9.3 to 20.0	Hours
Length of Stay	Cervical Foley & Misoprostol	3	Inter-Quartile Range 3 to 4	Days
Length of Stay	Misoprostol Only	3	Inter-Quartile Range 3 to 4	Days
Length of Stay	Cervical Foley Alone	3	Inter-Quartile Range 3 to 4	Days
Length of Stay	Cervical Foley & Pitocin	3	Inter-Quartile Range 3 to 4	Days
Severe RDS	Cervical Foley & Misoprostol	0		participants
Severe RDS	Misoprostol Only	1		participants

1 to 10 of 32Source ClinicalTrials.gov

See all 32 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Cervical Foley & Misoprostol	123
Overall Study	STARTED	Misoprostol Only	120
Overall Study	STARTED	Cervical Foley Alone	123
Overall Study	STARTED	Cervical Foley & Pitocin	125
Overall Study	COMPLETED	Cervical Foley & Misoprostol	123
Overall Study	COMPLETED	Misoprostol Only	120
Overall Study	COMPLETED	Cervical Foley Alone	123
Overall Study	COMPLETED	Cervical Foley & Pitocin	125
Overall Study	NOT COMPLETED	Cervical Foley & Misoprostol	0
Overall Study	NOT COMPLETED	Misoprostol Only	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events56

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Chorioamnionitis	Pregnancy, puerperium and perinatal conditions	Cervical Foley & Misoprostol	15	123	15
other	Chorioamnionitis	Pregnancy, puerperium and perinatal conditions	Misoprostol Only	9	120	9
other	Chorioamnionitis	Pregnancy, puerperium and perinatal conditions	Cervical Foley Alone	17	123	17
other	Chorioamnionitis	Pregnancy, puerperium and perinatal conditions	Cervical Foley & Pitocin	20	125	20
other	Endometritis	Pregnancy, puerperium and perinatal conditions	Cervical Foley & Misoprostol	0	123	0
other	Endometritis	Pregnancy, puerperium and perinatal conditions	Misoprostol Only	1	120	1
other	Endometritis	Pregnancy, puerperium and perinatal conditions	Cervical Foley Alone	0	123	0
other	Endometritis	Pregnancy, puerperium and perinatal conditions	Cervical Foley & Pitocin	0	125	0
other	Wound Infection	Pregnancy, puerperium and perinatal conditions	Cervical Foley & Misoprostol	1	123	1
other	Wound Infection	Pregnancy, puerperium and perinatal conditions	Misoprostol Only	1	120	1

1 to 10 of 56Source ClinicalTrials.gov

See all 56 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Cervical Foley & Misoprostol
Total, all-cause mortality	Misoprostol Only
Total, all-cause mortality	Cervical Foley Alone
Total, all-cause mortality	Cervical Foley & Pitocin
Total, other adverse events	Cervical Foley & Misoprostol	30	123
Total, other adverse events	Misoprostol Only	33	120
Total, other adverse events	Cervical Foley Alone	46	123
Total, other adverse events	Cervical Foley & Pitocin	46	125
Total, serious adverse events	Cervical Foley & Misoprostol	0	123
Total, serious adverse events	Misoprostol Only	0	120

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27824758	DERIVED	PubMed
36996264	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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API reference For AI assistants