NCT01635439

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Dec 2010

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

July 4, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 9, 2012

Completed
3 months until next milestone

Results Posted

Study results publicly available

October 4, 2012

Completed
Last Updated

February 6, 2014

Status Verified

January 1, 2014

Enrollment Period

11 months

First QC Date

July 4, 2012

Results QC Date

July 6, 2012

Last Update Submit

January 7, 2014

Conditions

Labor Pain

Outcome Measures

Primary Outcomes (1)

  • Induction to Delivery Interval

    24 hours

Secondary Outcomes (4)

  • Induction to Onset of Labor Interval

    24 hours

  • Uterine Hyper-stimulation Rate

    24 hours

  • Need for Syntocinon Augmentation

    24 hours

  • Normal Vaginal Delivery Rate

    24 hours

Study Arms (2)

Propess

ACTIVE COMPARATOR

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.

Drug: Propess

Prostin E2

ACTIVE COMPARATOR

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

Drug: Prostin E2

Interventions

PropessDRUG

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.

Also known as: Intravaginal PGE2 insert
Propess
Prostin E2DRUG

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.

Also known as: Dinoprostone (PGE2)vaginal tablets.
Prostin E2

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NWAFH, North west Armed Forces Hospital

Tabuk, Tabuk Region, Box 100 Tabuk, Saudi Arabia

Location

Related Publications (1)

  • 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.

    PMID: 30122579DERIVED

MeSH Terms

Conditions

Labor Pain

Interventions

Dinoprostone

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Results Point of Contact

Title
Ahmed Abdelaziz
Organization
NWAFH
webmaster@nwafh.med.sa
0096644411088

Study Officials

  • Ahmed Abdelaziz, M.D.

    North West Armed Forces Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer of Obstetrics & Gynecology/ Consultant of Obstetrics & Gynecology AFHSR

Study Record Dates

First Submitted

July 4, 2012

First Posted

July 9, 2012

Study Start

December 1, 2010

Primary Completion

November 1, 2011

Study Completion

December 1, 2011

Last Updated

February 6, 2014

Results First Posted

October 4, 2012

Record last verified: 2014-01

Locations

SA(1)