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Prostin and Propess in Induction of Labor

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ClinicalTrials.gov Identifier: NCT01635439
Recruitment Status : Completed
First Posted : July 9, 2012
Results First Posted : October 4, 2012
Last Update Posted : February 6, 2014
Sponsor:
Collaborator:
North West Armed Forces Hospital
Information provided by (Responsible Party):
Mohamed Ellaithy, Ain Shams University

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).

Condition or disease Intervention/treatment Phase
Labor Pain Drug: Propess Drug: Prostin E2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Induction of Labour: A Comparison Between Propess Vaginal Delivery System and Prostin E2 Vaginal Suppositories, A Randomized Controlled Trial.
Study Start Date : December 2010
Actual Primary Completion Date : November 2011
Actual Study Completion Date : December 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Propess
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
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 Name: Intravaginal PGE2 insert

Active Comparator: Prostin E2
PROSTIN E2 Vaginal Suppository, an oxytocic, contains dinoprostone as the naturally occurring prostaglandin E2 (PGE2)3 mg/suppository.
Drug: Prostin E2
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 Name: Dinoprostone (PGE2)vaginal tablets.




Primary Outcome Measures :
  1. Induction to Delivery Interval [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  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 ]


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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01635439


Locations
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Saudi Arabia
NWAFH, North west Armed Forces Hospital
Tabuk, Saudi Arabia, Box 100 Tabuk
Sponsors and Collaborators
Ain Shams University
North West Armed Forces Hospital
Investigators
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Principal Investigator: Ahmed Abdelaziz, M.D. North West Armed Forces Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mohamed Ellaithy, Lecturer of Obstetrics & Gynecology/ Consultant of Obstetrics & Gynecology AFHSR, Ain Shams University
ClinicalTrials.gov Identifier: NCT01635439    
Other Study ID Numbers: NWAFH2010-1
First Posted: July 9, 2012    Key Record Dates
Results First Posted: October 4, 2012
Last Update Posted: February 6, 2014
Last Verified: January 2014
Additional relevant MeSH terms:
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Labor Pain
Pain
Neurologic Manifestations
Signs and Symptoms
Dinoprostone
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs