Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

Pregnancy Clinical Trial

Official title:

Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01231126
• Other study ID #: 051/09
• Status: Completed
• Phase: Phase 4
• First received: October 29, 2010
• Last updated: November 15, 2010
• Start date: February 2008
• Est. completion date: January 2009

Study information

• Verified date: January 2009
• Source: Maternidade Escola Assis Chateaubriand
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

Methods: it was a study achieved with 101 pregnant women with indication to induced delivery labor that were evaluated by the hemoglobin dosage pre and post delivery for estimate the blood loss at delivery. Patients were submitted to transabdominal obstetric ultrasound and basal cardiotocography. 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. The control group was formed by 30 patients that began an spontaneously labor and 30 patients that achieved caesarians electively. The study of hemoglobin before and after delivery was evaluated through ANOVA to repeated measures, where it was verified the time effect (pre and post delivery) and the effect of the group (with and without use of misoprostol).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: January 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 14 Years to 40 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Induced Labor
• Pregnancy

Intervention

Drug:
• Misoprostol
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.

Locations

Country	Name	City	State
Brazil	Maternidade-Escola Assis Chateaubriand	Fortaleza	Ceará

Sponsors (1)

Lead Sponsor	Collaborator
Maternidade Escola Assis Chateaubriand

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	blood loss	To evaluate the blood loss in spontaneous vaginal deliveries and elective caesarians through the hemoglobin dosage pre and post delivery.	24 hours after delivery	No

External Links

•   site of Maternidade-Escola Assis Chateaubriand