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Oral Titrated Misoprostol for Induction of Labour

2014-08-27 03:18:46 | BioPortfolio

Summary

The purpose of this study is to compare effectiveness and safety of an oral titrated solution of misoprostol with vaginal misoprostol for induction of labour with an alive fetus.

Description

Several methods for induction of labour are available. However, the most effective and with less frequency of adverse effects is still unknown. Vaginal misoprostol has been used frequently to induce labour but other routes of administrations have been proposed, such as oral, sublingual and, more recently, oral titrated solution. The purpose of this study is to compare effectiveness and safety of this oral misoprostol titrated solution with vaginal misoprostol administration for induction of labour with an alive fetus. A randomized controlled double-blind trial will be carried in three hospitals: Instituto de Medicina Integral Prof. Fernando Figueira, Universidade Federal do Ceará and Instituto de Saúde Elpídio de Almeida, from November 2009 to November 2011. A total of 400 patients must be enrolled. Inclusion criteria are: a) indication for labour induction; b) term pregnancy with alive fetus; Bishop score less than six. Exclusion criteria are: a) age less than 18 years; b) previous uterine scar; c) nonvertex presentation; d) non-reassuring fetal status; e) fetal anomalies; f) fetal growth restriction; g) genital bleeding; h) tumors, malformations and/or ulcers of vulva, perineum or vagina. They will be randomized to receive an oral misoprostol titrated solution with vaginal placebo tablet or oral placebo solution with vaginal misoprostol tablet. Oral solution will have misoprostol at a concentration of 2mcg/ml or placebo. Vaginal tablets will have 25mcg of misoprostol or placebo. Oral solution dose will be 20mcg/hour (misoprostol) or 10ml/hour (placebo) in the first six hours with an increase of 20mcg/hour (10ml/hour) of misoprostol or placebo each six hours if labour does not start, until the maximum dose of 80mcg/hour or 40ml/hour in the first 24 hours. This maximum dose can be maintained for more 24 hours if needed. Vaginal misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 200mcg or eight tablets. Primary outcomes will be vaginal delivery within 24 hours, hyperstimulation syndrome, cesarean section, severe neonatal morbidity or perinatal death, serious maternal morbidity or maternal death. Secondary outcomes will be need of oxytocin for augmentation of labour, number of misoprostol doses needed to bring on labour, interval from first dose to labour and first dose to delivery, failed induction, tachysystole, uterine rupture, need of labour analgesia, instrumental delivery, side effects, maternal death, meconium, non-reassuring fetal heart rate, Apgar scores less than seven at 1st and 5th minutes, admission at neonatal intensive care unit, neonatal encephalopaty, perinatal death and women not satisfied.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Conditions

Labor, Induced

Intervention

Misoprostol, Misoprostol

Location

Instituto de Medicina Integral Professor Fernando Figueira (IMIP)
Recife
Pernambuco
Brazil
50070-550

Status

Not yet recruiting

Source

Instituto Materno Infantil Prof. Fernando Figueira

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:18:46-0400

Clinical Trials [825 Associated Clinical Trials listed on BioPortfolio]

A Comparison of Oral Misoprostol and Vaginal Misoprostol for Cervical Ripening and Induction of Labor

The purpose of this study is to study if misoprostol administered orally is at least as effective as misoprostol administered vaginally for cervical ripening and the induction of labor. Th...

Is More Than One Dose of Misoprostol Needed to Expedite Vaginal Delivery in a Patient With an Unripe Cervix?

The goal of this study is to determine whether inducing labor with just one dose of misoprostol, followed by treatment with oxytocin, will still be effective enough to increase the chances...

A Randomized Comparison of Transcervical Foley Bulb With Vaginal Misoprostol to Vaginal Misoprostol Alone for Induction of Labor

A randomized, prospective trial will be offered to women admitted to the Roosevelt Hospital labor floor for labor induction. The hypothesis is that the simultaneous use of a foley bulb tog...

Mifepristone and Misoprostol Versus Misoprostol Alone for Mid-trimester Termination of Pregnancy (14-21 Weeks LMP)

The primary goal of this study is to determine the clinical advantage of pre-treatment with mifepristone in second trimester misoprostol induction abortion. This will be a randomized contr...

Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor

Demonstrate that with concomitant and synchronous use of supracervical balloon and vaginal misoprostol for induction of labour, vaginal delivery is achieved in less time compared with vagi...

PubMed Articles [9209 Associated PubMed Articles listed on BioPortfolio]

Induction of Labor Using One Dose versus Multiple Doses of Misoprostol - A Randomized Controlled Trial.

Misoprostol is a common agent used to ripen the cervix and induce labor, yet there is no clear evidence of the optimal number of doses needed to achieve a higher rate of vaginal delivery.

The costs and cost effectiveness of providing second-trimester medical and surgical safe abortion services in Western Cape Province, South Africa.

In South Africa, access to second-trimester abortion services, which are generally performed using medical induction with misoprostol alone, is challenging for many women. We aimed to estimate the cos...

Mifepristone Pretreatment for the Medical Management of Early Pregnancy Loss.

Medical management of early pregnancy loss is an alternative to uterine aspiration, but standard medical treatment with misoprostol commonly results in treatment failure. We compared the efficacy and ...

Associations of hypertensive disorders of pregnancy and outcomes of labor induction with prostaglandin vaginal inserts.

To evaluate the association between hypertensive (HTNsive) disorders of pregnancy and outcomes of labor induction, in two cohorts of women induced with either misoprostol vaginal insert (MVI) or dinop...

Misoprostol for NSAID-induced small bowel erosions and ulcers.

Medical and Biotech [MESH] Definitions

Artificially induced UTERINE CONTRACTION. Generally, LABOR, OBSTETRIC is induced with the intent to cause delivery of the fetus and termination of pregnancy.

A synthetic analog of natural prostaglandin E1. It produces a dose-related inhibition of gastric acid and pepsin secretion, and enhances mucosal resistance to injury. It is an effective anti-ulcer agent and also has oxytocic properties.

The repetitive uterine contraction during childbirth which is associated with the progressive dilation of the uterine cervix (CERVIX UTERI). Successful labor results in the expulsion of the FETUS and PLACENTA. Obstetric labor can be spontaneous or induced (LABOR, INDUCED).

A change in the CERVIX UTERI with respect to its readiness to relax. The cervix normally becomes softer, more flexible, more distensible, and shorter in the final weeks of PREGNANCY. These cervical changes can also be chemically induced (LABOR, INDUCED).

The beginning of true OBSTETRIC LABOR which is characterized by the cyclic uterine contractions of increasing frequency, duration, and strength causing CERVICAL DILATATION to begin (LABOR STAGE, FIRST ).

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