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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03489798
Other study ID # MHST2016-04
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date April 5, 2018
Est. completion date September 15, 2018

Study information

Verified date October 2018
Source Saint Thomas Hospital, Panama
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 310
Est. completion date September 15, 2018
Est. primary completion date May 31, 2018
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
6 misoprostol
Up to 6 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6.
3 misoprostol
Up to 3 doses of 25ug of misoprostol applied every 6 hours. End point is cervical Bishop score > 6.

Locations

Country Name City State
Panama Saint Thomas Maternity Hospital Panama

Sponsors (2)

Lead Sponsor Collaborator
Saint Thomas Hospital, Panama Sistema Nacional de Investigadores de Panamá

Country where clinical trial is conducted

Panama, 

Outcome

Type Measure Description Time frame Safety issue
Primary Vaginal birth Number of patients that had a vaginal birth 48 hours
Secondary Maternal complications Number of patients that developed a maternal complication due to the use of misoprostol (abruptio placenta, postpartum bleeding, uterine atony). 48 hours
Secondary Fetal complications Number of patients that developed a fetal complication due to the use of misoprostol (stillbirth, fetal distress). 48 hours
See also
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Active, not recruiting NCT06324279 - Cervical Sliding Sign to Predict Outcome of Induction of Labor
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Active, not recruiting NCT06056141 - Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter Phase 4
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Completed NCT02477085 - Methods of Labor Induction and Perinatal Outcomes
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Completed NCT00451308 - Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml Phase 4
Not yet recruiting NCT05511727 - Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening N/A
Recruiting NCT02762942 - Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor Phase 4
Completed NCT01283022 - Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study) Phase 2
Recruiting NCT00684606 - Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor N/A
Recruiting NCT05759364 - The Effect of IV PAPAVERINE 80 mg Prior to Catheter Balloon Insertion on Bishop Score and Pain N/A
Recruiting NCT03854383 - Using Isosorbide Mononitrate in Reducing Time in Induction of Labor in Post Date Women Phase 2
Completed NCT01428037 - Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor Phase 3
Terminated NCT03752073 - Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix N/A
Recruiting NCT03045939 - Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours N/A