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

NCTNCT03138252Other idCRB + Oxytocin

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 180 participants (actual)
Sponsor: University Hospitals Cleveland Medical Center · Other
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: Nov 2014
Primary completion: Jul 2017
Completion: Jul 2017
First posted: 3 May 2017
Last update posted: 4 May 2022
Conditions: Cervical Ripening · Induction of Labor · Multiparity

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20142015201620172018

Ph 3
Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin
NCT03138252
Nov 2014 to Jul 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

OxytocinDrug

Arms2

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.
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.

Primary outcomes1

Outcomes the sponsor listed as primary.

Time From Cervical Ripening to Delivery
Time frame · Time to delivery
Registry description
Time from placement of cervical ripening balloon to delivery

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· Time to delivery

Time From Cervical Ripening to Delivery

Group	Value (hours)
Cervical Ripening Balloon Alone	16.88
Cervical Ripening Balloon + Oxytocin	13.13

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Cervical Ripening Balloon AloneMultiparous 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	0 / 90	0 / 90	0 / 90
Cervical Ripening Balloon + OxytocinMultiparous 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	0 / 90	2 / 90	0 / 90

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: Female
Age: from 18 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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