Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour
This study has been completed.
Sponsor:
Maternidade Escola Assis Chateaubriand
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | October 29, 2010 | ||||||||
| Last Updated Date | November 15, 2010 | ||||||||
| Start Date ICMJE | February 2008 | ||||||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01231126 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour | ||||||||
| Official Title ICMJE | Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour | ||||||||
| 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. |
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| 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). |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Phase 4 | ||||||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
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| Condition ICMJE |
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| Intervention ICMJE | 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 |
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| Study Arm (s) |
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| Publications * | ElSedeek MSh, Awad EE, ElSebaey SM. Evaluation of postpartum blood loss after misoprostol-induced labour. BJOG. 2009 Feb;116(3):431-5. | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Completed | ||||||||
| Enrollment ICMJE | 161 | ||||||||
| Completion Date | January 2009 | ||||||||
| Primary Completion Date | January 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | 14 Years to 40 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01231126 | ||||||||
| Other Study ID Numbers ICMJE | 051/09 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Paulo César Praciano de Sousa, Maternidade Escola Assis Chateaubriand | ||||||||
| Study Sponsor ICMJE | Maternidade Escola Assis Chateaubriand | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Maternidade Escola Assis Chateaubriand | ||||||||
| Verification Date | January 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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