|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
16 December 2017 |
|
Main ID: |
NCT03016442 |
|
Date of registration:
|
08/01/2017 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Dinoprostone Vaginal Insert Versus Double Balloon Catheter for Preinduction Cervical Ripening
|
|
Scientific title:
|
|
|
Date of first enrolment:
|
November 2016 |
|
Target sample size:
|
200 |
|
Recruitment status: |
Recruiting |
|
URL:
|
https://clinicaltrials.gov/show/NCT03016442 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
|
|
Phase:
|
Phase 2
|
|
|
Countries of recruitment
|
|
Turkey
| | | | | | | |
|
Contacts
|
|
Name:
|
Gonca Yetkin Yildirim, MD |
|
Address:
|
|
|
Telephone:
|
+90 5323532205 |
|
Email:
|
goncayetkinyildirim@gmail.com |
|
Affiliation:
|
|
|
|
Name:
|
Gonca Yetkin Yildirim, MD |
|
Address:
|
|
|
Telephone:
|
+90 532 3532205 |
|
Email:
|
goncayetkinyildirim@gmal.com |
|
Affiliation:
|
|
| |
|
Key inclusion & exclusion criteria
|
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.
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Labor Induction
|
|
Intervention(s)
|
|
Drug: Dinoprostone
|
|
Device: Cook Double Balloon Catheter
|
|
Primary Outcome(s)
|
|
Vaginal delivery after initiation of ripening within 24 hours
[Time Frame: 24 hours]
|
|
Secondary Outcome(s)
|
|
Occurence of cesarean section
[Time Frame: 24 hours]
|
|
Secondary ID(s)
|
|
KanuniSSTRH -3
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|