Labor Induction and Maternal BMI, Comparison of Different Pre-induction Cervical Ripening Methods

Obesity Clinical Trial

Official title:

Labor Induction and Maternal BMI: Comparison of Different Pre-induction Cervical Ripening Methods: The Cook Double Balloon Catheter vs PGE1 Tablets in Lean, Overweight, and Obese Women. A Prospective Randomized Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02223949
• Other study ID #: 0033-14-HYMC
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: August 21, 2014
• Last updated: August 21, 2014
• Start date: October 2014
• Est. completion date: November 2016

Study information

• Verified date: August 2014
• Source: Hillel Yaffe Medical Center
• Contact: Saja Murra Anabosy, MD
• Phone: +972 50 9260067
• Email: saja83[@]gmail.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate whether mechanical cervical ripening (using the Cook double balloon catheter) is superior or inferior to pharmacological agents (PGE1) in overweight and obese women undergoing labor induction.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 624
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Age 18 years of age or older.

• Diagnosed to be pregnant (al least 37 weeks of gestation) with a medical indication for labor induction, including: postdate pregnancy, preeclampsia, gestational or chronic hypertension, Gestational Diabetes Mellitus at term, Oligohydramnios, Polyhydramnios, fetal growth restriction, maternal background disease necessitating delivery, Isoimmunisation, maternal Thrombophilia, intrahepatic cholestasis of pregnancy.

• Having a Bishop score of 4 points or less.

• Diagnosed as having singleton pregnancy at term (37 weeks at least) in a vertex presentation, with intact membranes, and absence of significant regular uterine contraction.

• Willingness to comply with the protocol for the duration of the study.

• Has agreed and signed an informed consent after given oral and written explanation.

Exclusion Criteria:

• Anay contraindication for a vaginal delivery (i.e. placenta previa, non vertex presentation, estimated fetal weight of less than 4500 gr).

• Ruptured membranes.

• Previous cesarian section or presence of any uterine scar.

• Documented labor with four or more spontanous uterine contractions per hour.

• Suspected fetal distress necessitating immediate intervention.

• Proven malignancy of the cervix.

• Active vaginal bleeding.

• Active inflammatory or purulent condition of the lower genital tract.

• Active asthma.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Labor Complications
• Obesity
• Obstetric Labor Complications

Intervention

Device:
• Cook double balloon catheter

Drug:
• PGE1 tablet

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera

Sponsors (1)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cesarian section rate		24 hours	No
Secondary	Incidence of excessive uterine activity Incidence of excessive uterine activity	At least 6 uterine contractions per 10- minutes period, or hyperstimulation, if combined with fetal heart rate abnormalities, or hypertonus defined as single contraction of 2-minute duration.	24 hours	No
Secondary	Active labor onset		24 hours	No
Secondary	Proportion of vaginal delivery		24 hours	No
Secondary	Treatment failure	Proportion of subjects with unfavorable/unchanged Bishop score 12-24 hours after ripening	12-24 hours	No
Secondary	The ripening-to-delivery time interval		24 hours	No
Secondary	Need for oxytocin induction and/or augmentation of labor		24 hours	No
Secondary	Mode of delivery	NVD vs. instrumental	24 hours	No
Secondary	Intra-partum or postpartum fever		48 hours	No
Secondary	Incidence of meconium staining		24 hours	No
Secondary	The proportion of neonates with 5-minute Apgar scores of less than 7		48 hours	No
Secondary	The number of neonates who were admitted to the neonatal intensive care unit		48 hours	No
Secondary	morbidity and mortality	Number of cases of serious maternal and/or neonatal morbidity or death (including uterine rupture, maternal admission to the intensive care unit, maternal septicemia, placental abruption, hemorrhage at required blood transfusion, hysterectomy, neonatal seizures, birth asphyxia, meconium aspiration syndrome, or neonatal sepsis).	48 hours	No