Dinoprostone Vaginal Insert Versus Double Balloon Catheter for Preinduction Cervical Ripening

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03016442
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Duration (Months): 5
• Patients Per Site Per Month: 40.3

Study Details

Study Description

Brief Summary

Effıcacy of dinoprostone vaginal insert versus double- balloon catheter among women in the induction of labor

Condition or Disease	Intervention/Treatment	Phase
Labor Induction	Device: Cook Double Balloon Catheter; Drug: Dinoprostone	Phase 2

Detailed Description

The study will be conducted in the Department of Obstetrics and Gynecology at Kanuni Sultan Süleyman Education and Research Hospital ,İstanbul, Turkey, with approval of the local institutional review board. All the participants will give informed consent before beginning of the study. Women who agree to participate will be first stratified into nulliparous and multiparous groups. Randomisation will be carried out by using sealed opaque envelopes with a piece of paper inside marked 'PGE2 vaginal insert' or 'Double-balloon catheter'. Envelopes will be prepared in blocks of 20 (10 PGE2 vaginal insert and 10 double-balloon catheters) for each stratified group. Envelopes will be then shuffled and placed in boxes marked 'nulliparous' and 'multiparous'. The investigator is not blinded to the allocation procedure. The allocated envelope will be opened by the clinician performing the initial vaginal examination just prior to that examination.

In the group assigned to mechanical ripening , a double- balloon catheter (Cook Cervical Ripener Balloon,Cook OB/GYN,Spencer IN) is inserted into cervical canal under direct visualisation during a sterile speculum examination. Once both balloon enter the cervical canal, the first balloon is filled with 40 ml saline above the level of the internal os. The second (vaginal) balloon is the inflated with 20 ml of saline.Then both of them are filled with 60 ml of saline. The external end of the device is taped without traction to the medial aspect of the woman's thigh. After completion of the device placement, patients undergo continous fetal heart rate monitoring for 30 min then are allowed to ambulate.The double ballon is placed for 12 hours .

In the group randomly assigned to vaginal insert is placed high in the vaginal fornix, the patients are monitored at least 1 hour for fetal heart rate and uterine activity and they are allowed to ambulate.

After 12 hours oxytocin isadministered using a standard dose regimen to all patients.

Primary and secondary outcomes are measured.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Study Start Date: Nov 1, 2016
• Anticipated Primary Completion Date: Apr 1, 2017
• Anticipated Study Completion Date: Apr 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cook double balloon catheter A double- balloon catheter (Cook Cervical Ripener Balloon,Cook OB/GYN,Spencer IN) is inserted into cervical canal under direct visualisation during a sterile speculum examination İt is placed for 12 hours	Device: Cook Double Balloon Catheter; A double- balloon catheter (Cook Cervical Ripener Balloon,Cook OB/GYN,Spencer IN) is inserted into cervical canal under direct visualisation during a sterile speculum examination.İt is placed for 12 hours; Other Names: The Obstetric Cook Double Balloon Catheter
Active Comparator: Dinoprostone 10 mg of dinoprostone in a hydrogel insert is placed high in the vaginal fornix. İt is placed for 12 hours.It is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.	Drug: Dinoprostone; 10 mg of dinoprostone in a hydrogel insert is placed high in the vaginal fornix. İt is placed for 12 hours.It is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.; Other Names: Dinoprostone vaginal insert

Outcome Measures

Primary Outcome Measures

1. Vaginal delivery after initiation of ripening within 24 hours [24 hours]

Secondary Outcome Measures

1. Occurence of cesarean section [24 hours]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 45 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Eligible women have obstetric or medical indications for labor induction with intact membranes

• singleton pregnancies,

• vertex presentations

• low Bishop scores ≤6

• gestational age ≥34 w

• reassuring fetal heart tracing on admission.

Exclusion Criteria:

• Exclusion criteria are placenta previa

• unexplained vaginal bleeding

• nonvertex presentation

• intrauterine fetal death

• prior cesarean delivery

• any scarred uterus

• any other contraindications for vaginal delivery.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi	Istanbul		Turkey	34325

Sponsors and Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Related Info

Publications

• Connolly KA, Kohari KS, Rekawek P, Smilen BS, Miller MR, Moshier E, Factor SH, Stone JL, Bianco AT. A randomized trial of Foley balloon induction of labor trial in nulliparas (FIAT-N). Am J Obstet Gynecol. 2016 Sep;215(3):392.e1-6. doi: 10.1016/j.ajog.2016.03.034. Epub 2016 Mar 24.
• Cromi A, Ghezzi F, Uccella S, Agosti M, Serati M, Marchitelli G, Bolis P. A randomized trial of preinduction cervical ripening: dinoprostone vaginal insert versus double-balloon catheter. Am J Obstet Gynecol. 2012 Aug;207(2):125.e1-7. doi: 10.1016/j.ajog.2012.05.020. Epub 2012 Jun 1.

• Responsible Party: Gonca Yetkin Yildirim, MD, Kanuni Sultan Suleyman Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT03016442
• Other Study ID Numbers: KanuniSSTRH -3
• First Posted: Jan 10, 2017
• Last Update Posted: Jan 10, 2017
• Last Verified: Nov 1, 2016

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Gonca Yetkin Yildirim, MD, Kanuni Sultan Suleyman Training and Research Hospital: Double balloon catheter; Dinoprostone; Labor induction
• Additional relevant MeSH terms: Dinoprostone

Study Results

No Results Posted as of Jan 10, 2017