Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 281 for:    Panama

Comparison of Two Protocols of Misoprostol (PGE1) and the Rate of Cesarean Section Due to Failed Induction.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03489798
Recruitment Status : Completed
First Posted : April 5, 2018
Last Update Posted : October 12, 2018
Sponsor:
Collaborator:
Sistema Nacional de Investigadores de Panamá
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Brief Summary:
To compare two protocols of misoprostol use for cervical ripening: 3 doses (25 ug vaginal each) or up to six doses, every six hours, until an adequate cervical condititon was achieved (BIshop score > 6). In the first group, after 3 doses, the patient was sent to the delivery room for induction with oxytocin and in case of failure, a cesarean section was indicated for this reason. In the second group, up to six doses were used in a similar fashion. Rates of success were evaluated, as well as maternal and fetal complications.

Condition or disease Intervention/treatment Phase
Induction of Labor Procedure: 6 misoprostol Procedure: 3 misoprostol Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 310 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of Two Protocols of Misoprostol (PGE1) and Their Effect on the Rate of Cesarean Section Due to Failed Induction. A Randomized, Controlled Trial.
Actual Study Start Date : April 5, 2018
Actual Primary Completion Date : May 31, 2018
Actual Study Completion Date : September 15, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
Drug Information available for: Misoprostol

Arm Intervention/treatment
Experimental: 6 Misoprostol
Up to six doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6.
Procedure: 6 misoprostol
Up to 6 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6.
Other Name: Prostaglandin E1 25 ug dose

Active Comparator: 3 misoprostol
Up to 3 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6.
Procedure: 3 misoprostol
Up to 3 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6.
Other Name: Prostaglandin E1 25 ug dose




Primary Outcome Measures :
  1. Vaginal birth [ Time Frame: 48 hours ]
    Number of patients that had a vaginal birth


Secondary Outcome Measures :
  1. Maternal complications [ Time Frame: 48 hours ]
    Number of patients that developed a maternal complication due to the use of misoprostol (abruptio placenta, postpartum bleeding, uterine atony).

  2. Fetal complications [ Time Frame: 48 hours ]
    Number of patients that developed a fetal complication due to the use of misoprostol (stillbirth, fetal distress).



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women between 34 and 42 weeks of gestation.
  • Obstetric indication for termination of pregnancy.
  • No fetal evidence of fetal distress

Exclusion Criteria:

  • Any contraindication for the use of misoprostol.
  • Oligohydramnios.

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): NCT03489798


Locations
Layout table for location information
Panama
Saint Thomas Maternity Hospital
Panama, Panama
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Sistema Nacional de Investigadores de Panamá

Layout table for additonal information
Responsible Party: Osvaldo A. Reyes T., Investigator - Head: Research Department, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT03489798     History of Changes
Other Study ID Numbers: MHST2016-04
First Posted: April 5, 2018    Key Record Dates
Last Update Posted: October 12, 2018
Last Verified: October 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Induction of labor
Misoprostol
Failed induction
Additional relevant MeSH terms:
Layout table for MeSH terms
Alprostadil
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Platelet Aggregation Inhibitors
Vasodilator Agents
Urological Agents