Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy

Obesity Clinical Trial

Official title:

Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02788305
• Other study ID #: 9898
• 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
• 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).

Related Conditions & MeSH terms

• Induced; Birth
• Obesity

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