Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

NCT01231126 | Completed Phase 4 DMC

• 1 other identifier: 051/09
• Study Type: interventional
• Target: 161
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the blood loss in induced vaginal delivery by misoprostol and caesarians section with induction attempt.

Conditions

Pregnancy; Induced Labor

Keywords

Induced labor; Misoprostol; Postpartum blood; Erythrocyte indices; Vaginal delivery

Outcome Measures

Primary Outcomes (1)

• Vaginal delivery

  Procedures were taken for induced labor delivery with misoprostol 25mcg, by vaginal rout. The pills were administered each 6 hours in a maximum number of six.

  54 hours after the first pills

Secondary Outcomes (1)

• blood loss

  24 hours after delivery

Study Arms (4)

spontaneous vaginal deliveries

PLACEBO COMPARATOR

Drug: Misoprostol

elective caesarians

PLACEBO COMPARATOR

Drug: Misoprostol

induced vaginal delivery by misoprostol

EXPERIMENTAL

Drug: Misoprostol

caesarians section with induction attempt

EXPERIMENTAL

Drug: Misoprostol

Interventions

Misoprostol DRUG

Procedures were taken for induced labor delivery with misoprostol 25mcg, by vaginal rout. The pills were administered each 6 hours in a maximum number of six.

Also known as: Citotec

caesarians section with induction attempt; elective caesarians; induced vaginal delivery by misoprostol; spontaneous vaginal deliveries

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Indication of early elective delivery by induction of labor (pre-eclampsia, HELLP syndrome, chronic hypertension, prolonged gestation, diabetes mellitus, gestational diabetes, heart disease, thyroid disease;
• pregnancy with living fetus;
• vertex cephalic presentation;
• estimated fetal weight by ultrasound \> 2500g and \<4000g;
• Amniotic fluid index (AFI)\> 5 cm, except in cases of premature rupture of membranes in which AFI \<5 cm would be allowed;
• cardiotocography (CTG) antepartum normal;
• Bishop Score less than or equal to 6;
• Determination of hemoglobin pre and post-partum.

You may not qualify if:

• Prior Cesarean section;
• previous uterine scar by myomectomy;
• Fetal presentation anomalous;
• Evidence of fetal abnormal (CTG, Ultrasound or Doppler);
• Fetal growth restriction;
• Gestation multiple;
• genital bleeding;
• tumors, malformations and / or ulceration in the region vulvoperineal and birth canal;
• No determination of hemoglobin pre-and post-partum;

Sponsors & Collaborators

• Maternidade Escola Assis Chateaubriand: lead

Study Sites (1)

Maternidade-Escola Assis Chateaubriand

Fortaleza, Ceará, 60430-270, Brazil

Location

Related Publications (1)

• ElSedeek MSh, Awad EE, ElSebaey SM. Evaluation of postpartum blood loss after misoprostol-induced labour. BJOG. 2009 Feb;116(3):431-5. doi: 10.1111/j.1471-0528.2008.02054.x.

  PMID: 19187376 RESULT

Related Links

• site of Maternidade-Escola Assis Chateaubriand

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Paulo César Praciano de Sousa, Mestre

  Maternidade Escola Assis Chateaubriand

  PRINCIPAL INVESTIGATOR

• Francisco Edson de Lucena Feitosa, Doutor

  Maternidade Escola Assis Chateaubriand

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: October 29, 2010
• First Posted: November 1, 2010
• Study Start: February 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: January 1, 2009
• Last Updated: November 16, 2010

Record last verified: 2009-01

Locations

BR (1)