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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02223949
Other study ID # 0033-14-HYMC
Secondary ID
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


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
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