PregnancyPhase 4NCT01231126
Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour
A Phase 4 study testing Misoprostol in people with Pregnancy and Induced Labor, run by Maternidade Escola Assis Chateaubriand at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 14 to 40 years, women only
- Conditions the study is for
- Pregnancy, Induced Labor
- What is being tested?
- Misoprostol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 161 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2008to Jan 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 40 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Prior Cesarean section;
- previous uterine scar by myomectomy;
- Fetal presentation anomalous;
- Evidence of fetal abnormal (CTG, Ultrasound or Doppler);
- Fetal growth restriction;
- Gestation multiple;
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- genital bleeding;
- tumors, malformations and / or ulceration in the region vulvoperineal and birth canal;
- No determination of hemoglobin pre-and post-partum;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Maternidade-Escola Assis Chateaubriand
Fortaleza, Ceará, 60430-270
About this study
The purpose of this study is to evaluate the blood loss in induced vaginal delivery by misoprostol and caesarians section with induction attempt.
Read the 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).
- Conditions
- Pregnancy, Induced Labor
- Being tested
- Misoprostol
- Keywords
- Induced labor, Misoprostol, Postpartum blood, Erythrocyte indices, Vaginal delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Also called Citotec
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.
| Study group | Role | What they receive |
|---|---|---|
| spontaneous vaginal deliveries | Placebo comparator | Not described Receives: Drug: Misoprostol |
| elective caesarians | Placebo comparator | Not described Receives: Drug: Misoprostol |
| induced vaginal delivery by misoprostol | Experimental | Not described Receives: Drug: Misoprostol |
| caesarians section with induction attempt | Experimental | Not described Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 54 hours after the first pills
Secondary outcomes (1)
blood loss
To evaluate the blood loss in spontaneous vaginal deliveries and elective caesarians through the hemoglobin dosage pre and post delivery.
Measured: 24 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startFeb 2008
- Primary completionJan 2009
- Study completionJan 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 161 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maternidade Escola Assis Chateaubriand
- Sponsor type
- University, hospital or other
- Investigators
- Paulo César Praciano de Sousa, Mestre, Principal investigator, Maternidade Escola Assis ChateaubriandFrancisco Edson de Lucena Feitosa, Doutor, Study director, Maternidade Escola Assis Chateaubriand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231126
- Sponsor's protocol ID
- 051/09
- Status last verified
- Jan 2009
- First submitted
- 29 Oct 2010
- Last updated
- 16 Nov 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 19187376
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation the Blood Loss in Pregnancies With Misoprostol-induced Labour
- ClinicalTrials.gov ID
- NCT01231126
- Acronym / sponsor ID
- 051/09
- Conditions
- Pregnancy, Induced Labor
- Keywords
- Induced labor, Misoprostol, Postpartum blood, Erythrocyte indices, Vaginal delivery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 161 participants (actual)
- Lead sponsor
- Maternidade Escola Assis ChateaubriandUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Jan 2009 (actual)
- Study completion
- Jan 2009 (actual)
- First posted
- 1 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (9 listed)
- Prior Cesarean section;
- previous uterine scar by myomectomy;
- Fetal presentation anomalous;
- Evidence of fetal abnormal (CTG, Ultrasound or Doppler);
- Fetal growth restriction;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MisoprostolAlso: CitotecProcedures 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. | Drug | caesarians section with induction attempt, elective caesarians, induced vaginal delivery by misoprostol, spontaneous vaginal deliveries |
Primary outcome
Vaginal delivery
Time frame: 54 hours after the first pills
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.
1 secondary outcome
blood loss
Time frame: 24 hours after delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2010.
- Results publication: PubMed 19187376ElSedeek 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.
- site of Maternidade-Escola Assis ChateaubriandLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Paulo César Praciano de Sousa, Mestre principal investigator
Maternidade Escola Assis Chateaubriand
Francisco Edson de Lucena Feitosa, Doutor study director
Maternidade Escola Assis Chateaubriand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Misoprostol in people with Pregnancy and Induced Labor, run by Maternidade Escola Assis Chateaubriand at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal delivery (time frame: 54 hours after the first pills). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01231126, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Nov 2010.