A Randomized Trial of Induction Methods in Premature Rupture of Membranes

Induction of Labor Affected Fetus / Newborn Clinical Trial

Official title:

A Randomized Trial of Foley Bulb and PGE2 for Labor Induction in Premature Rupture of Membranes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03744078
• Other study ID #: 47
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: January 1, 2019

Study information

• Verified date: November 2018
• Source: Zeynep Kamil Maternity and Pediatric Research and Training Hospital
• Contact: ahmet eser
• Phone: 905067136880
• Email: hicoice[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the addition of transcervical Foley catheter balloon and vaginal prostaglandin E2 induction in premature rupture of membranes. Half of participants will be used combine transcervical Foley catheter balloon and vaginal prostaglandin E2, while the other half will be used alone vaginal prostaglandin E2.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: January 1, 2019
• Est. primary completion date: December 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. singleton pregnancy,

2. gestational age =34 weeks,

3. rupture of membranes,

4. cephalic presentation,

5. bishop score =5,

6. had less than three uterine contractions in every 10 minutes.

Exclusion Criteria:

1. Patients who had contraindications for vaginal delivery,

2. previous uterine surgery,

3. fetal malpresentation,

4. multifetal pregnancy,

5. more than three contractions in 10 minutes,

6. contraindications to prostaglandins,

7. a category II or III fetal heart rate pattern,

8. anomalous fetus,

9. fetal demise

10. women with immediate delivery indications -

Related Conditions & MeSH terms

• Fetal Membranes, Premature Rupture
• Induction of Labor Affected Fetus / Newborn
• Premature Birth
• Preterm Premature Rupture of Fetal Membranes
• Rupture

Intervention

Device:
• Foley balloon catheter
18-F Foley catheter which filling with 60 mL of saline solution will be placed into the cervix

Locations

Country	Name	City	State
Turkey	Doga	Istanbul	Kucukcekmece
Turkey	Zeynep Kamil Education and Research Hospital	Istanbul	Uskudar

Sponsors (1)

Lead Sponsor	Collaborator
Zeynep Kamil Maternity and Pediatric Research and Training Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	induction-to- delivery time	the length of time between the beginning of induction and the end of labor	an average of one year
Secondary	tachysystole	uterine contractions more than 3 in 10 minutes	an average of one year
Secondary	chorioamnionitis	clinical chorioamnionitis(Maternal fever and Fetal tachycardia >160/min and Maternal tachycardia >100/min	an average of one year
Secondary	postpartum hemorrhage	abnormal uterine bleeding after birth	an average of one year
Secondary	neonatal outcome	APGAR scores	an average of one year
Secondary	admission to neonatal intensive care unit	admission to neonatal intensive care unit	an average of one year