Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

This study has been completed.
Sponsor:
Information provided by:
Maternidade Escola Assis Chateaubriand
ClinicalTrials.gov Identifier:
NCT01231126
First received: October 29, 2010
Last updated: November 15, 2010
Last verified: January 2009

October 29, 2010
November 15, 2010
February 2008
January 2009   (final data collection date for primary outcome measure)
Vaginal delivery [ Time Frame: 54 hours after the first pills ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01231126 on ClinicalTrials.gov Archive Site
blood loss [ Time Frame: 24 hours after delivery ] [ Designated as safety issue: No ]
To evaluate the blood loss in spontaneous vaginal deliveries and elective caesarians through the hemoglobin dosage pre and post delivery.
Same as current
Not Provided
Not Provided
 
Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour
Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

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

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).

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Pregnancy
  • Induced Labor
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.
Other Name: Citotec
  • Placebo Comparator: spontaneous vaginal deliveries
    Intervention: Drug: Misoprostol
  • Placebo Comparator: elective caesarians
    Intervention: Drug: Misoprostol
  • Experimental: induced vaginal delivery by misoprostol
    Intervention: Drug: Misoprostol
  • Experimental: caesarians section with induction attempt
    Intervention: Drug: Misoprostol
ElSedeek MSh, Awad EE, ElSebaey SM. Evaluation of postpartum blood loss after misoprostol-induced labour. BJOG. 2009 Feb;116(3):431-5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
161
January 2009
January 2009   (final data collection date for primary outcome measure)

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;
Female
14 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01231126
051/09
Yes
Paulo César Praciano de Sousa, Maternidade Escola Assis Chateaubriand
Maternidade Escola Assis Chateaubriand
Not Provided
Principal Investigator: Paulo César Praciano de Sousa, Mestre Maternidade Escola Assis Chateaubriand
Study Director: Francisco Edson de Lucena Feitosa, Doutor Maternidade Escola Assis Chateaubriand
Maternidade Escola Assis Chateaubriand
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP