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

NCT03138252 | Completed Phase 3 Results DMC

• 1 other identifier: CRB + Oxytocin
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Ripening; Induction of Labor; Multiparity

Outcome Measures

Primary Outcomes (1)

• Time From Cervical Ripening to Delivery

  Time from placement of cervical ripening balloon to delivery

  Time to delivery

Study Arms (2)

Cervical Ripening Balloon Alone

ACTIVE COMPARATOR

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

Cervical Ripening Balloon + Oxytocin

ACTIVE COMPARATOR

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

Interventions

Oxytocin DRUG

Cervical Ripening Balloon + Oxytocin; Cervical Ripening Balloon Alone

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

Alison Bauer

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Interventions

Oxytocin

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Limitations and 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.

Results Point of Contact

• Title: Dr. Alison Bauer
• Organization: University Hospitals Cleveland Medical Center

alison.bauer@uhhospitals.org

216-844-3787

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2014
• First Posted: May 3, 2017
• Study Start: November 1, 2014
• Primary Completion: July 1, 2017
• Study Completion: July 1, 2017
• Last Updated: May 4, 2022
• Results First Posted: May 4, 2022

Record last verified: 2022-05

Locations

US (1)