Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin

• Sponsor: University Hospitals Cleveland Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT03138252
• Collaborator: (none)
• Enrollment: 180
• Location: 1
• Arms: 2
• Actual Duration (Months): 32
• Patients Per Site Per Month: 5.6

Study Details

Study Description

Brief Summary

Study Purpose: The purpose of this study is to determine the optimal method for induction of labor in multiparous women who present with an unfavorable cervix.

Hypothesis: Our hypothesis is that using oxytocin while the cervical ripening balloon is in place will result in more rapid labor courses, without increasing morbidity or increasing the need for operative delivery.

Condition or Disease	Intervention/Treatment	Phase
Cervical Ripening; Induction of Labor; Multiparity	Drug: Oxytocin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 180 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Randomized Controlled Trial: Cervical Ripening Balloon With and Without Oxytocin for Cervical Ripening in Multiparas
• Actual Study Start Date: Nov 1, 2014
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Cervical Ripening Balloon Alone Multiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.	Drug: Oxytocin
Active Comparator: Cervical Ripening Balloon + Oxytocin Multiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital.	Drug: Oxytocin

Outcome Measures

Primary Outcome Measures

1. Time From Cervical Ripening to Delivery [Time to delivery]

   Time from placement of cervical ripening balloon to delivery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Age > 18 years

• Gestational age > 34 + 0/7 weeks

• Prior spontaneous vaginal delivery

• Clinical or U/S EFW of <4500 grams

• Singleton gestation

• Cervical dilation <2 cm

Exclusion Criteria:

• Any contraindication to cervical ripening balloon, pitocin, or vaginal delivery

• Placenta within 2 cm of cervical os

• Placental abruption, chorioamninoitis, or systemic infection prior to induction

• Rupture of membranes prior to induction ->1 prior C/S

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alison Bauer	Cleveland	Ohio	United States	44106

Sponsors and Collaborators

• University Hospitals Cleveland Medical Center

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Oct 1, 2014

More Information

Publications

None provided.

• Responsible Party: University Hospitals Cleveland Medical Center
• ClinicalTrials.gov Identifier: NCT03138252
• Other Study ID Numbers: CRB + Oxytocin
• First Posted: May 3, 2017
• Last Update Posted: May 4, 2022
• Last Verified: May 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Additional relevant MeSH terms: Oxytocin

Study Results

Participant Flow

Arm/Group Title	Cervical Ripening Balloon Alone	Cervical Ripening Balloon + Oxytocin
Arm/Group Description	Multiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital. Oxytocin	Multiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital. Oxytocin
Period Title: Overall Study
STARTED	90	90
COMPLETED	90	90
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Cervical Ripening Balloon Alone	Cervical Ripening Balloon + Oxytocin	Total
Arm/Group Description	Multiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital. Oxytocin	Multiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital. Oxytocin	Total of all reporting groups
Overall Participants	90	90	180
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	90 100%	90 100%	180 100%
>=65 years	0 0%	0 0%	0 0%
Sex: Female, Male (Count of Participants)
Female	90 100%	90 100%	180 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	1 1.1%	0 0%	1 0.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	77 85.6%	76 84.4%	153 85%
White	9 10%	13 14.4%	22 12.2%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	3 3.3%	1 1.1%	4 2.2%
Region of Enrollment (participants) [Number]
United States	90 100%	90 100%	180 100%

Outcome Measures

1. Primary Outcome

Title	Time From Cervical Ripening to Delivery
Description	Time from placement of cervical ripening balloon to delivery
Time Frame	Time to delivery

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cervical Ripening Balloon Alone	Cervical Ripening Balloon + Oxytocin
Arm/Group Description	Multiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital. Oxytocin	Multiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital. Oxytocin
Measure Participants	90	90
Median (Inter-Quartile Range) [hours]	16.88	13.13

Adverse Events

Time Frame	36 hours
Arm/Group Title	Cervical Ripening Balloon Alone		Cervical Ripening Balloon + Oxytocin
Arm/Group Description	Multiparous women will begin cervical ripening with a cervical ripening balloon alone. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital. Oxytocin		Multiparous women will begin cervical ripening with a cervical ripening balloon and simultaneous oxytocin. After the balloon is expelled or removed, induction of labor will proceed with pitocin per standard protocol at MacDonald Women's Hospital. Oxytocin
All Cause Mortality
	Cervical Ripening Balloon Alone		Cervical Ripening Balloon + Oxytocin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/90 (0%)		0/90 (0%)
Serious Adverse Events
	Cervical Ripening Balloon Alone		Cervical Ripening Balloon + Oxytocin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/90 (0%)		2/90 (2.2%)
Pregnancy, puerperium and perinatal conditions
Peripartum Hysterectomy	0/90 (0%)		1/90 (1.1%)
Unanticipated neonatal intensive care unit admission	0/90 (0%)		1/90 (1.1%)
Other (Not Including Serious) Adverse Events
	Cervical Ripening Balloon Alone		Cervical Ripening Balloon + Oxytocin
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/90 (0%)		0/90 (0%)

Limitations/Caveats

Providers were not masked to the intervention group. We recruited 72%, but the inability to recruit all eligible patients is a potential source of selection bias. This study was not powered to assess adverse maternal/neonatal outcomes.

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.