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Prostin and Propess in Induction of Labor

Primary Purpose

Labor Pain

Status
Completed
Phase
Phase 3
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Propess
Prostin E2
Sponsored by
Ain Shams University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Gestational age 37 weeks or more
  • Singleton pregnancy
  • Cephalic presentation.

Exclusion Criteria:

  • Previous cesarean section
  • Any contraindication for vaginal delivery
  • Suspected Cephalo-Pelvic Disproportion
  • Unexplained antepartum Hemorrhage

Sites / Locations

  • NWAFH, North west Armed Forces Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Propess

Prostin E2

Arm Description

Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h.

PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.

Outcomes

Primary Outcome Measures

Induction to Delivery Interval

Secondary Outcome Measures

Induction to Onset of Labor Interval
Uterine Hyper-stimulation Rate
Need for Syntocinon Augmentation
Normal Vaginal Delivery Rate

Full Information

First Posted
July 4, 2012
Last Updated
January 7, 2014
Sponsor
Ain Shams University
Collaborators
North West Armed Forces Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01635439
Brief Title
Prostin and Propess in Induction of Labor
Official Title
Induction of Labour: A Comparison Between Propess Vaginal Delivery System and Prostin E2 Vaginal Suppositories, A Randomized Controlled Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
November 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
Collaborators
North West Armed Forces Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of the study was to compare the safety and efficacy of two agents used in induction of labor Propess (Controlled release dinoprostone, PGE2, pessary) and Prostin E2 (Dinoprostone vaginal Tablet).
Detailed Description
A controlled release hydrophilic matrix (Controlled Therapeutics Ltd., East Kilbride, Scotland) which provides a gradual release of dinoprostone (prostaglandin E2) was introduced in 1995 (Propess, Ferring Pharmaceuticals). This preparation is used for the initiation or enhancement of cervical ripening in women at or after term with a singleton pregnancy and a cephalic presentation. Prostaglandin E2 causes softening and dilatation of the cervix and subsequently produces uterine contractions which may induce labour.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Propess
Arm Type
Active Comparator
Arm Description
Propess insert is a preparation of PGE2 packaged in a hydrogel polymer matrix and designed for slow intravaginal release of 10 mg dinoprostone at a rate of 0.3 mg/h.
Arm Title
Prostin E2
Arm Type
Active Comparator
Arm Description
PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Intervention Type
Drug
Intervention Name(s)
Propess
Other Intervention Name(s)
Intravaginal PGE2 insert
Intervention Description
The vaginal insert is removed 24 h after the application. It is only to be removed earlier in case of the onset of active labour, the rupture of the membranes, or at the occurrence of hyperstimulation.
Intervention Type
Drug
Intervention Name(s)
Prostin E2
Other Intervention Name(s)
Dinoprostone (PGE2)vaginal tablets.
Intervention Description
3 mg tab is placed in the posterior vaginal fornix. dose can be repeated every 6 hours till onset of active labour, the rupture of the membranes, or the occurrence of hyper-stimulation.
Primary Outcome Measure Information:
Title
Induction to Delivery Interval
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Induction to Onset of Labor Interval
Time Frame
24 hours
Title
Uterine Hyper-stimulation Rate
Time Frame
24 hours
Title
Need for Syntocinon Augmentation
Time Frame
24 hours
Title
Normal Vaginal Delivery Rate
Time Frame
24 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Gestational age 37 weeks or more Singleton pregnancy Cephalic presentation. Exclusion Criteria: Previous cesarean section Any contraindication for vaginal delivery Suspected Cephalo-Pelvic Disproportion Unexplained antepartum Hemorrhage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmed Abdelaziz, M.D.
Organizational Affiliation
North West Armed Forces Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
NWAFH, North west Armed Forces Hospital
City
Tabuk
ZIP/Postal Code
Box 100 Tabuk
Country
Saudi Arabia

12. IPD Sharing Statement

Citations:
PubMed Identifier
30122579
Citation
Abdelaziz A, Mahmoud AA, Ellaithy MI, Abees SH. Pre-induction cervical ripening using two different dinoprostone vaginal preparations: A randomized clinical trial of tablets and slow release retrievable insert. Taiwan J Obstet Gynecol. 2018 Aug;57(4):560-566. doi: 10.1016/j.tjog.2018.06.016.
Results Reference
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Prostin and Propess in Induction of Labor

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