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

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ClinicalTrials.gov Identifier: NCT02732522
Recruitment Status : Completed
First Posted : April 8, 2016
Last Update Posted : April 8, 2016
Sponsor:
Information provided by (Responsible Party):
Andrés Conde, Universidad de la Republica

Brief 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.

Condition or disease Intervention/treatment Phase
Cervical Ripening Drug: Sublingual misoprostol Drug: Vaginal misoprostol Phase 4

Detailed 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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Comparison Between Vaginal and Sublingual Misoprostol 50 µg for Cervical Ripening Prior to Induction of Labor: Randomized Clinical Trial
Study Start Date : October 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arm Intervention/treatment
Experimental: Misoprostol sublingual Drug: Sublingual misoprostol
Active Comparator: Misoprostol vaginal Drug: Vaginal misoprostol



Primary Outcome Measures :
  1. Bishop score at 6 hours after administration of misoprostol [ Time Frame: 6 hours ]

Secondary Outcome Measures :
  1. Number of participants with Tachysystole [ Time Frame: 6 hours ]
    Tachysystole was defined as the presence of at least 6 uterine contractions in 10 minutes.

  2. Number of patients who ended their pregnancy by caesarean section [ Time Frame: From administration of misoprostol to birth, up to 3 days. ]
  3. Requirement of further doses of misoprostol [ Time Frame: From administration of misoprostol to birth, up to 3 days. ]
  4. Labor within 6 hours [ Time Frame: 6 hours ]
  5. Apgar score at 1 minute [ Time Frame: At the first minute after delivery ]
  6. Apgar score at 5 minutes [ Time Frame: At the fifth minute after delivery ]
  7. pH cord blood gas [ Time Frame: At delivery ]


Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Andrés Conde, M.D., Universidad de la Republica
ClinicalTrials.gov Identifier: NCT02732522     History of Changes
Other Study ID Numbers: CMVS-01
First Posted: April 8, 2016    Key Record Dates
Last Update Posted: April 8, 2016
Last Verified: April 2016
Keywords provided by Andrés Conde, Universidad de la Republica:
misoprostol
induction of labor
sublingual
Additional relevant MeSH terms:
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Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics