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Completed

NCT Number: NCT01635439

Prostin and Propess in Induction of Labor

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).

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Key information

Conditions

Labor Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

NWAFH, North west Armed Forces Hospital

Tabuk, Tabuk Region, Box 100 Tabuk, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Propess

Drug

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.

Other names: Intravaginal PGE2 insert

Prostin E2

Drug

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.

Other names: Dinoprostone (PGE2)vaginal tablets.

Primary outcomes

  1. Induction to Delivery Interval

    Time frame: 24 hours

Secondary outcomes

  1. Induction to Onset of Labor Interval

    Time frame: 24 hours

  2. Uterine Hyper-stimulation Rate

    Time frame: 24 hours

  3. Need for Syntocinon Augmentation

    Time frame: 24 hours

  4. Normal Vaginal Delivery Rate

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Collaborators

  • North West Armed Forces Hospital

Registry information

Official study title

Induction of Labour: A Comparison Between Propess Vaginal Delivery System and Prostin E2 Vaginal Suppositories, A Randomized Controlled Trial.

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jul 9, 2012
Registry last updated
Feb 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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