Oral Titrated Misoprostol for Induction of Labour

NCT ID: NCT00992524

Last Updated: 2011-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2011-06-30

Brief 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.

Detailed 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.

Conditions

Labor, Induced

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Oral Titrated Misoprostol Solution

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

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.

Vaginal Misoprostol

Group Type: ACTIVE_COMPARATOR

Misoprostol

Intervention Type: DRUG

Vaginal tablets will have 25mcg of misoprostol or placebo.

Interventions

Misoprostol

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.

Intervention Type: DRUG

Misoprostol

Vaginal tablets will have 25mcg of misoprostol or placebo.

Intervention Type: DRUG

Other Intervention Names

Prostokos; Cytotec; Prostokos; Cytotec

Eligibility Criteria

Inclusion Criteria

• Indication for labour induction
• Term pregnancy with alive fetus
• Bishop score less than six

Exclusion Criteria

• Age less than 18 years
• Previous uterine scar
• Nonvertex presentation
• Non-reassuring fetal status
• Fetal anomalies
• Fetal growth restriction
• Genital bleeding
• Tumors, malformations and/or ulcers of vulva, perineum or vagina

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Instituto de Saúde Elpidio de Almeida

UNKNOWN

Sponsor Role: collaborator

Universidade Federal do Ceara

OTHER

Sponsor Role: collaborator

Instituto Materno Infantil Prof. Fernando Figueira

OTHER

Sponsor Role: lead

Responsible Party

Instituto de Medicina Integral Prof. Fernando Figueira (IMIP)

Principal Investigators

Alex SR Souza, Phd student

Role: STUDY_CHAIR

Professor Fernando Figueira Integral Medicine Institute

Melania MR Amorim, Phd

Role: STUDY_DIRECTOR

Professor Fernando Figueira Integral Medicine Institute

Aurélio AR Costa, PhD

Role: PRINCIPAL_INVESTIGATOR

Professor Fernando Figueira Integral Medicine Institute

Locations

Instituto de Medicina Integral Professor Fernando Figueira (IMIP)

Recife, Pernambuco, Brazil

Countries

Brazil

References

Souza AS, Feitosa FE, Costa AA, Pereira AP, Carvalho AS, Paixao RM, Katz L, Amorim MM. Titrated oral misoprostol solution versus vaginal misoprostol for labor induction. Int J Gynaecol Obstet. 2013 Dec;123(3):207-12. doi: 10.1016/j.ijgo.2013.06.028. Epub 2013 Sep 3.

Reference Type: DERIVED

PMID: 24112746 (View on PubMed)

Orange FA, Passini R Jr, Melo AS, Katz L, Coutinho IC, Amorim MM. Combined spinal-epidural anesthesia and non-pharmacological methods of pain relief during normal childbirth and maternal satisfaction: a randomized clinical trial. Rev Assoc Med Bras (1992). 2012 Jan-Feb;58(1):112-7.

Reference Type: DERIVED

PMID: 22392325 (View on PubMed)

Other Identifiers

ORALTIMI

Identifier Type: -

Identifier Source: org_study_id