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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02788305
Other study ID # 9898
Secondary ID
Status Completed
Phase N/A
First received May 20, 2016
Last updated October 13, 2017
Start date May 1, 2016
Est. completion date June 30, 2017

Study information

Verified date October 2017
Source Kasr El Aini Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

- 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.


Recruitment information / eligibility

Status Completed
Enrollment 288
Est. completion date June 30, 2017
Est. primary completion date May 30, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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).

Study Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Egypt Kasr wl aini hospitals Cairo Greater Cairo

Sponsors (1)

Lead Sponsor Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary route of delivery vaginal or caesarean section. Partogram is used to access the progress of labour 48 hours from the start of induction
Secondary maternal haemorrhage Calculating number of soaked pads 48 hours from the start of induction
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