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

Primary Purpose

Obesity, Labor Complications

Status

Unknown status

Phase

Phase 2

Locations

Israel

Study Type

Interventional

Intervention

Cook double balloon catheter

PGE1 tablet

About this trial

This is an interventional treatment trial for Obesity focused on measuring Obesity, Labor complications, Induction of labor, Mechanical cervical ripening

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

Hillel Yaffe Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cook double balloon catheter

PGE1 tablet insertion

Arm Description

Insertion of the Cook double balloon catheter to the cervix until both balloons are properly located in the cervical canal. After properly located it is inflated with 20 ml of saline. Then both balloons are additionally inflated to a total of 80 ml each balloon. Twelve hours later the balloons are deflated and the device is removed.

Insertion of 25 mg PGE1 (Prostaglandin E1) tablet is inserted in the posterior fornix. The patient woll the be instructed to stay in bed for the next 60 minutes. After six hours a repeated dose will be administered. Total of 4 PGE1 doses within 24 hours.

Outcomes

Primary Outcome Measures

Cesarian section rate

Secondary Outcome Measures

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.

Active labor onset

Proportion of vaginal delivery

Treatment failure

Proportion of subjects with unfavorable/unchanged Bishop score 12-24 hours after ripening

The ripening-to-delivery time interval

Need for oxytocin induction and/or augmentation of labor

Mode of delivery

NVD vs. instrumental

Intra-partum or postpartum fever

Incidence of meconium staining

The proportion of neonates with 5-minute Apgar scores of less than 7

The number of neonates who were admitted to the neonatal intensive care unit

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).

Full Information

NCT ID

NCT02223949

First Posted

August 21, 2014

Last Updated

August 21, 2014

Sponsor

Hillel Yaffe Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT02223949

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

August 2014

Overall Recruitment Status

Unknown status

Study Start Date

October 2014 (undefined)

Primary Completion Date

October 2016 (Anticipated)

Study Completion Date

November 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hillel Yaffe Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Labor Complications

Keywords

Obesity, Labor complications, Induction of labor, Mechanical cervical ripening

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

624 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cook double balloon catheter

Arm Type

Experimental

Arm Description

Arm Title

PGE1 tablet insertion

Arm Type

Active Comparator

Arm Description

Intervention Type

Device

Intervention Name(s)

Cook double balloon catheter

Intervention Type

Drug

Intervention Name(s)

PGE1 tablet

Other Intervention Name(s)

Prostaglandin E1

Primary Outcome Measure Information:

Title

Cesarian section rate

Time Frame

24 hours

Secondary Outcome Measure Information:

Title

Incidence of excessive uterine activity Incidence of excessive uterine activity

Description

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.

Time Frame

24 hours

Title

Active labor onset

Time Frame

24 hours

Title

Proportion of vaginal delivery

Time Frame

24 hours

Title

Treatment failure

Description

Proportion of subjects with unfavorable/unchanged Bishop score 12-24 hours after ripening

Time Frame

12-24 hours

Title

The ripening-to-delivery time interval

Time Frame

24 hours

Title

Need for oxytocin induction and/or augmentation of labor

Time Frame

24 hours

Title

Mode of delivery

Description

NVD vs. instrumental

Time Frame

24 hours

Title

Intra-partum or postpartum fever

Time Frame

48 hours

Title

Incidence of meconium staining

Time Frame

24 hours

Title

The proportion of neonates with 5-minute Apgar scores of less than 7

Time Frame

48 hours

Title

The number of neonates who were admitted to the neonatal intensive care unit

Time Frame

48 hours

Title

morbidity and mortality

Description

Time Frame

48 hours

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Saja Murra Anabosy, MD

Phone

+972 50 9260067

saja83@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

Asnat Walfisch, MD

Phone

+972 50 4492200

asnatwalfisch@yahoo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Saja Murra Anabosy, MD

Organizational Affiliation

Hillel Yaffe Medical Center

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Asnat Walfisch, MD

Organizational Affiliation

Hillel Yaffe Medical Center

Official's Role

Study Chair

Facility Information:

Facility Name

Hillel Yaffe Medical Center

City

Hadera

ZIP/Postal Code

169

Country

Israel

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Saja Murra Anobosy, MD

Phone

+972 50 9260067

saja83@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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