Trial · NCT01127581

Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery

NCT01127581, Phase 3, Completed, Ferring Pharmaceuticals; results first posted 2014-03-07

3 sourcestrials-2026-11-12-0.4.0

Cite this record

ConductScience Library. Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery. Trials, record NCT01127581. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01127581

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Trial

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

Title: Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery
NCT number: NCT01127581
Status: Completed
Phases: Phase 3
Enrollment: 1,358 participants, actual
Lead sponsor: Ferring Pharmaceuticals
Conditions: Reducing Time to Vaginal Delivery, Cervical Ripening, Induction of Labor
Interventions: MVI 200, Dinoprostone Vaginal Insert (DVI)
First posted: 2010-05-21
Last updated: 2014-05-01
Results first posted: 2014-03-07

Source ClinicalTrials.gov

Registered outcomes11

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

List	Outcome	Time frame	Description
Primary	Time to Vaginal Delivery During the First Hospital Admission	Interval from study drug administration to vaginal delivery (average 24 hours)
Primary	Incidence of Cesarean Delivery During the First Hospital Admission	Interval from study drug administration to cesarean delivery (average 24 hours)
Secondary	Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission	Interval from study drug administration to neonate delivery (average 24 hours)
Secondary	Time to Active Labor During the First Hospital Admission	Interval from study drug administration to active labor (average 12 hours)	Active labor was defined as progressive cervical dilatation to 4 cm with any frequency of contractions OR rhythmic, firm, adequate quality uterine contractions causing progressive cervical change occurring at a frequency of 3 or more in 10 minutes and lasting 45 seconds or more.
Secondary	Incidence of Pre-delivery Oxytocin During the First Hospital Admission	At least 30 minutes after study drug removal	Percentage of participants in receipt of Oxytocin for induction after study drug removal.
Secondary	Incidence of Vaginal Delivery Within 12 Hours	Interval from study drug administration to vaginal delivery within 12 hours
Secondary	Incidence of Any Delivery Within 24 Hours	Interval from study drug administration to delivery of neonate within 24 hours
Secondary	Incidence of Any Delivery Within 12 Hours	Interval from study drug administration to delivery of neonate within 12 hours
Secondary	Incidence of Vaginal Delivery Within 24 Hours	Interval from study drug administration to vaginal delivery within 24 hours
Secondary	Incidence of Vaginal Delivery	Interval from study drug administration to vaginal delivery (average 24 hours)

1 to 10 of 11Source ClinicalTrials.gov

See all 11 registered outcomes

Outcomes11

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Time to Vaginal Delivery During the First Hospital Admission	Interval from study drug administration to vaginal delivery (average 24 hours)	Subjects who underwent a cesarean delivery during the first hospitalization were censored using the longest time interval from study drug administration to cesarean delivery, independent of treatment assignment. Subjects who were discharged prior to delivery or withdrew consent prior to delivery were also censored.	minutes	MEDIAN
PRIMARY	Incidence of Cesarean Delivery During the First Hospital Admission	Interval from study drug administration to cesarean delivery (average 24 hours)	Analysis was based on a between-treatment-group difference in the safety population. Subjects discharged prior to delivery, withdrew early without having a cesarean delivery or were lost-to-follow up were classified as not having the event.	percentage of participants	NUMBER
SECONDARY	Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission	Interval from study drug administration to neonate delivery (average 24 hours)	Subjects who did not deliver during the first hospitalization were censored at the time of labour and delivery discharge.	minutes	MEDIAN
SECONDARY	Time to Active Labor During the First Hospital Admission	Interval from study drug administration to active labor (average 12 hours)	Intention-to-Treat (ITT) population	minutes	MEDIAN
SECONDARY	Incidence of Pre-delivery Oxytocin During the First Hospital Admission	At least 30 minutes after study drug removal	Analysis population includes subjects who delivered during the first hospitalization.	percentage of participants	NUMBER
SECONDARY	Incidence of Vaginal Delivery Within 12 Hours	Interval from study drug administration to vaginal delivery within 12 hours	Intention-to-Treat (ITT) population	percentage of participants	NUMBER
SECONDARY	Incidence of Any Delivery Within 24 Hours	Interval from study drug administration to delivery of neonate within 24 hours	Intention-to-Treat (ITT) Population	percentage of participants	NUMBER
SECONDARY	Incidence of Any Delivery Within 12 Hours	Interval from study drug administration to delivery of neonate within 12 hours	Intention-to-Treat (ITT) Population	percentage of participants	NUMBER
SECONDARY	Incidence of Vaginal Delivery Within 24 Hours	Interval from study drug administration to vaginal delivery within 24 hours	Intention-to-Treat (ITT) Population	percentage of participants	NUMBER
SECONDARY	Incidence of Vaginal Delivery	Interval from study drug administration to vaginal delivery (average 24 hours)	The Intention-to-Treat (ITT) population was used for all secondary efficacy analyses.	percentage of participants	NUMBER

1 to 10 of 11Source ClinicalTrials.gov

See all 11 outcomes

Results by group26

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

Outcome	Group	Value	Spread	Units
Time to Vaginal Delivery During the First Hospital Admission	MVI 200	1292.00	95% Confidence Interval 1200.00 to 1402.00	minutes
Time to Vaginal Delivery During the First Hospital Admission	Dinoprostone Vaginal Insert (DVI)	1968.50	95% Confidence Interval 1812.00 to 2093.00	minutes
Incidence of Cesarean Delivery During the First Hospital Admission	MVI 200	25.96	95% Confidence Interval 22.70 to 29.43	percentage of participants
Incidence of Cesarean Delivery During the First Hospital Admission	Dinoprostone Vaginal Insert (DVI)	27.06	95% Confidence Interval 23.75 to 30.57	percentage of participants
Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission	MVI 200	1096.50	95% Confidence Interval 1031.00 to 1170.00	minutes
Time to Any Delivery (Vaginal or Cesarean) During the First Hospital Admission	Dinoprostone Vaginal Insert (DVI)	1639.50	95% Confidence Interval 1573.00 to 1731.00	minutes
Time to Active Labor During the First Hospital Admission	MVI 200	726.50	95% Confidence Interval 719.00 to 773.00	minutes
Time to Active Labor During the First Hospital Admission	Dinoprostone Vaginal Insert (DVI)	1116.50	95% Confidence Interval 1083.00 to 1352.00	minutes
Incidence of Pre-delivery Oxytocin During the First Hospital Admission	MVI 200	48.1	95% Confidence Interval 44.24 to 51.92	percentage of participants
Incidence of Pre-delivery Oxytocin During the First Hospital Admission	Dinoprostone Vaginal Insert (DVI)	74.1	95% Confidence Interval 70.58 to 77.35	percentage of participants

1 to 10 of 26Source ClinicalTrials.gov

See all 26 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	MVI 200	678
Overall Study	STARTED	Dinoprostone Vaginal Insert (DVI)	680
Overall Study	COMPLETED	MVI 200	678
Overall Study	COMPLETED	Dinoprostone Vaginal Insert (DVI)	680
Overall Study	NOT COMPLETED	MVI 200	0
Overall Study	NOT COMPLETED	Dinoprostone Vaginal Insert (DVI)	0

Source ClinicalTrials.gov

Adverse events172

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	Abnormal labour affecting foetus +	Pregnancy, puerperium and perinatal conditions	MVI 200	59	678	62
other	Abnormal labour affecting foetus +	Pregnancy, puerperium and perinatal conditions	Dinoprostone Vaginal Insert (DVI)	19	680	19
other	Arrested labour +	Pregnancy, puerperium and perinatal conditions	MVI 200	96	678	96
other	Arrested labour +	Pregnancy, puerperium and perinatal conditions	Dinoprostone Vaginal Insert (DVI)	128	680	129
other	Caput succedaneum *	Pregnancy, puerperium and perinatal conditions	MVI 200	58	678	58
other	Caput succedaneum *	Pregnancy, puerperium and perinatal conditions	Dinoprostone Vaginal Insert (DVI)	60	680	60
other	Chorioamnionitis +	Pregnancy, puerperium and perinatal conditions	MVI 200	38	678	38
other	Chorioamnionitis +	Pregnancy, puerperium and perinatal conditions	Dinoprostone Vaginal Insert (DVI)	59	680	59
other	Foetal heart rate disorder +	Pregnancy, puerperium and perinatal conditions	MVI 200	124	678	138
other	Foetal heart rate disorder +	Pregnancy, puerperium and perinatal conditions	Dinoprostone Vaginal Insert (DVI)	138	680	160

1 to 10 of 172Source ClinicalTrials.gov

See all 172 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	MVI 200
Total, all-cause mortality	Dinoprostone Vaginal Insert (DVI)
Total, other adverse events	MVI 200	520	678
Total, other adverse events	Dinoprostone Vaginal Insert (DVI)	533	680
Total, serious adverse events	MVI 200	130	678
Total, serious adverse events	Dinoprostone Vaginal Insert (DVI)	107	680

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
23857539	DERIVED	PubMed
25758619	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 comparisons1

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

Comparison
MVI 200 vs Dinoprostone Vaginal Insert (DVI): serious adverse events

Source Trial comparisons

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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GET https://conductscience.org/api/trials/v1/NCT01127581/results?page=2

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