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Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

Primary Purpose

Pregnancy, Induced Labor

Status

Completed

Phase

Phase 4

Locations

Brazil

Study Type

Interventional

Intervention

Misoprostol

About this trial

This is an interventional treatment trial for Pregnancy focused on measuring Induced labor, Misoprostol, Postpartum blood, Erythrocyte indices, Vaginal delivery

Eligibility Criteria

14 Years - 40 Years (Child, Adult)FemaleDoes not accept healthy volunteers

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;

Sites / Locations

Maternidade-Escola Assis Chateaubriand

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

spontaneous vaginal deliveries

elective caesarians

induced vaginal delivery by misoprostol

caesarians section with induction attempt

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

blood loss

To evaluate the blood loss in spontaneous vaginal deliveries and elective caesarians through the hemoglobin dosage pre and post delivery.

Full Information

NCT ID

NCT01231126

First Posted

October 29, 2010

Last Updated

November 15, 2010

Sponsor

Maternidade Escola Assis Chateaubriand

1. Study Identification

Unique Protocol Identification Number

NCT01231126

Brief Title

Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

Official Title

Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

Study Type

Interventional

2. Study Status

Record Verification Date

January 2009

Overall Recruitment Status

Completed

Study Start Date

February 2008 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

January 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Maternidade Escola Assis Chateaubriand

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pregnancy, Induced Labor

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

161 (Actual)

8. Arms, Groups, and Interventions

Arm Title

spontaneous vaginal deliveries

Arm Type

Placebo Comparator

Arm Title

elective caesarians

Arm Type

Placebo Comparator

Arm Title

induced vaginal delivery by misoprostol

Arm Type

Experimental

Arm Title

caesarians section with induction attempt

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Misoprostol

Other Intervention Name(s)

Citotec

Intervention Description

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.

Primary Outcome Measure Information:

Title

Vaginal delivery

Description

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.

Time Frame

54 hours after the first pills

Secondary Outcome Measure Information:

Title

blood loss

Description

To evaluate the blood loss in spontaneous vaginal deliveries and elective caesarians through the hemoglobin dosage pre and post delivery.

Time Frame

24 hours after delivery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

14 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

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;

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Paulo César Praciano de Sousa, Mestre

Organizational Affiliation

Maternidade Escola Assis Chateaubriand

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Francisco Edson de Lucena Feitosa, Doutor

Organizational Affiliation

Maternidade Escola Assis Chateaubriand

Official's Role

Study Director

Facility Information:

Facility Name

Maternidade-Escola Assis Chateaubriand

City

Fortaleza

State/Province

Ceará

ZIP/Postal Code

60430-270

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

19187376

Citation

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.

Results Reference

result

Links:

URL

http://www.meac.ufc.br

Description

site of Maternidade-Escola Assis Chateaubriand

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Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour

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