Comparison Between Vaginal and Sublingual Misoprostol 50 µg for Cervical Ripening Prior to Induction of Labor

Cervical Ripening Clinical Trial

— CMVS  

Official title:

Comparison Between Vaginal and Sublingual Misoprostol 50 µg for Cervical Ripening Prior to Induction of Labor: Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02732522
• Other study ID #: CMVS-01
• 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:

A randomized, single blind clinical trial, was performed. Inclusion criteria were all pregnant women admitted at Pereira Rossell Hospital Center with gestational ages between 32/0 and 41/6 according to first trimester sonogram, with a viable fetus in cephalic presentation, with estimated fetal weight lower than 4000 gr, without contraindications for vaginal birth, to whom induction of labor with misoprostol had been previously indicated, from 8 to 20 hours 7 days a week. Protocol counted with approval of the Ethics Commission of the Pereira Rossell Hospital. All participants gave written informed consent before the study began. Once there was confirmation that the patient met the inclusion criteria, information was given and consent form was signed, the patient entered the study and the intervention was randomized. Randomization was computer generated in permuted blocks of 2 by an epidemiologist from our Service, and the result was in a sealed and opaque envelope which was opened at the time of administering the medication. Prior to administration of the medication, an Obstetrician or Obstetrics resident who was not familiar with the administration route assigned to the patient assessed through vaginal examination the characteristics of the cervix in terms of Bishop score. Afterwards, a technician from the investigation team administered the misoprostol according to the assigned route (50 µg misoprostol vaginal or sublingual).

Tachysystole was defined as the presence of at least 6 uterine contractions in 10 minutes.

Primary result was defined as the clinically significant variation (of at least 2 points) of the Bishop score at 6 hours after administration of 50 µg misoprostol. Secondary results were defined as the presence of tachysystole, frequency of vaginal birth and cesarean section, frequency in which new doses were needed to continue with induction of labor and frequency with which labor was diagnosed at 6 hours of administration of misoprostol. Neonatal results included Apgar score at 1 and 5 minutes and pH value in umbilical cord gasometry. Final analysis was made according to intention to treat.

In order to detect a difference in the mean of Bishop score of 2 points, using a standard deviation of 2, with a 90% power, reaching a confidence interval of 95%, a population of 49 patients was required for each group.

Randomization was done in permuted blocks of 2, using a table of randomized numbers. Group 1 included those patients who received sublingual misoprostol and group 2 those patients who received vaginal misoprostol. Analysis was done in statistical package SPSS (reg) V16. For continuous variables a mean and standard deviation were described; for categorical variables absolute frequency and percentage were described. For statistical analysis a 2-tiled independent t-test was used, in order to compare the mean of the two groups. Also, chi-squared test and Fisher´s exact test were used to compare proportions among the two groups where it corresponds.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: January 2016
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All pregnant women admitted at Pereira Rossell Hospital Center

• Gestational ages between 32/0 and 41/6 according to first trimester sonogram

• A viable fetus in cephalic presentation

• Estimated fetal weight lower than 4000 gr

• Without contraindications for vaginal birth

• Whom induction of labor with misoprostol had been previously indicated, from 8 to 20 hours 7 days a week.

Exclusion Criteria:

• Does not meet inclusion criteria.

Study Design

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

Related Conditions & MeSH terms

• Cervical Ripening

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