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Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy

NCT ID: NCT02788305

Last Updated: 2017-10-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

288 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-05-01

Study Completion Date

2017-06-30

Brief Summary

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This study investigate the progression of labour in 144 normal weight pregnant women (BMI \<30) and 144 obese pregnant women (BMI \>30) , not in labor admitted for induction of labor. These women are to be investigated for success of induction of labor.

Detailed Description

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* This prospective study will be conducted for 144 obese and 144 non obese ), post date (\>41 wks), not in labor.
* Woman is classified as obese if BMI \>=30.
* Prolonged pregnancy was defined as delivery on or after (41+0 weeks) of gestation.
* First informed consent will be obtained.
* Determination of gestational age
* Proper history taking, general and abdominal examinations will be done then digital examination will be performed to determine bishop score.
* And obstetric U/S scan will be done and by which the following data will be obtained :

* Fetal biometry
* Fetal heart activity
* Presentation
* Localization of the placenta.
* Amount of amniotic fluid.
* Exclude multifetal pregnancy.
* Induction of labor will be done using vaginal misoprostol according to the estimated Bishop score.

Conditions

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Obesity Induced; Birth

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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non obese

BMI\<30. Misoprostol is given for induction of labour according to Bishop score

Misoprostol

Intervention Type DRUG

Misoprostol 25 micrograms every 6 hours will be given to obese and non obese groups

obese

BMI\>30. Misoprostol is given for induction of labour according to Bishop score

Misoprostol

Intervention Type DRUG

Misoprostol 25 micrograms every 6 hours will be given to obese and non obese groups

Interventions

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Misoprostol

Misoprostol 25 micrograms every 6 hours will be given to obese and non obese groups

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Pregnant woman.

* Post date \>= 41 weeks.
* Absent onset of labor.
* Patient acceptance to join the study after signing an informed consent.

Exclusion Criteria

* Placenta previa and or vasa previa.
* Previous caesarean section(CS).
* Multiple gestation
* Any patient who will refuse to be a part of the study.
* Intra- uterine fetal death (IUFD).
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kasr El Aini Hospital

OTHER

Sponsor Role lead

Responsible Party

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heba mahmoud ibrahim marie

lecturer at kaselaini hospitals

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Heba M Marie, M.D.

Role: PRINCIPAL_INVESTIGATOR

KasrElaini Hospital

Locations

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Kasr wl aini hospitals

Cairo, Greater Cairo, Egypt

Site Status

Countries

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Egypt

References

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Maged AM, El-Semary AM, Marie HM, Belal DS, Hany A, Taymour MA, Omran EF, Elbaradie SMY, Mohamed MAK. Effect of maternal obesity on labor induction in postdate pregnancy. Arch Gynecol Obstet. 2018 Jul;298(1):45-50. doi: 10.1007/s00404-018-4767-8. Epub 2018 Apr 2.

Reference Type DERIVED
PMID: 29610945 (View on PubMed)

Other Identifiers

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9898

Identifier Type: -

Identifier Source: org_study_id