Dinoprostone Vaginal Insert Versus Double Balloon Catheter for Preinduction Cervical Ripening

Kanuni Sultan Suleyman Training and Research Hospital

Status and phase: Unknown; Phase 2

Conditions: Labor Induction

Treatments: Drug: Dinoprostone; Device: Cook Double Balloon Catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT03016442

KanuniSSTRH -3

Details and patient eligibility

About

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

Full 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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 2 patient groups

Cook double balloon catheter

Experimental group

Description:

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

Treatment:

Device: Cook Double Balloon Catheter

Dinoprostone

Active Comparator group

Description:

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.

Treatment:

Drug: Dinoprostone