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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02732522
Other study ID # CMVS-01
Secondary ID
Status Completed
Phase Phase 4
First received March 28, 2016
Last updated April 4, 2016
Start date October 2014
Est. completion date January 2016

Study information

Verified date April 2016
Source Universidad de la Republica
Contact n/a
Is FDA regulated No
Health authority Uruguay: Ministry of Health
Study type Interventional

Clinical Trial Summary

To analyze whether there is a statistically significant difference in the modifications present in the uterine cervix 6 hours after administration of misoprostol 50 µg through vaginal versus sublingual routes.


Description:

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Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Sublingual misoprostol

Vaginal misoprostol


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Universidad de la Republica

Outcome

Type Measure Description Time frame Safety issue
Primary Bishop score at 6 hours after administration of misoprostol 6 hours No
Secondary Number of participants with Tachysystole Tachysystole was defined as the presence of at least 6 uterine contractions in 10 minutes. 6 hours Yes
Secondary Number of patients who ended their pregnancy by caesarean section From administration of misoprostol to birth, up to 3 days. No
Secondary Requirement of further doses of misoprostol From administration of misoprostol to birth, up to 3 days. No
Secondary Labor within 6 hours 6 hours No
Secondary Apgar score at 1 minute At the first minute after delivery No
Secondary Apgar score at 5 minutes At the fifth minute after delivery No
Secondary pH cord blood gas At delivery No
See also
  Status Clinical Trial Phase
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Withdrawn NCT00953641 - Vaginal Misoprostol for Cervical Ripening Prior to Endometrial Biopsy Phase 3
Completed NCT01127581 - Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery Phase 3
Completed NCT00374621 - Trial of Cervical Ripening and Labor Induction Using Misoprostol With or Without Intravaginal Isosorbide Mononitrate N/A
Recruiting NCT05864326 - Heated Saline in Cervical Balloon for Labor Induction, a RCT N/A
Active, not recruiting NCT02975167 - Patient Satisfaction During Outpatient Versus Inpatient Foley Catheter Induction of Labor N/A
Recruiting NCT02738177 - Misoprostol Versus Effox as Cervical Ripening Agent Prior Surgical Evacuation Phase 2
Completed NCT03138252 - Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin Phase 3
Recruiting NCT01720394 - Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert Phase 4
Completed NCT00468520 - Adjuvant Oxytocin for Preinduction Ripening With a Foley catheter--a Clinical Trial 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
Completed NCT00886860 - The Comparison of Efficacy for Cervical Ripening in Labor Induction Between Titrated and Conventional Oral Misoprostol Phase 4
Recruiting NCT01156948 - Misoprostol For Nulliparous Women Before Hysteroscopy Phase 3
Completed NCT00504465 - Combined Agent Randomized Trial of Induction of Labor N/A
Completed NCT01428037 - Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor Phase 3
Not yet recruiting NCT00815542 - Induction of Labor in Oligohydramnios Phase 3
Completed NCT01170819 - Double Balloon Catheter Versus Dinoprostone Vaginal Insert for Cervical Ripening. Phase 4
Completed NCT00346840 - Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour Phase 2
Completed NCT00442663 - Trial of Foley Catheter With and Without Extra-Amniotic Saline Infusion for Labor Induction N/A