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Completed

NCT Number: NCT02788305

Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy

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.

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Key information

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Kasr wl aini hospitals

Cairo, Greater Cairo, 11956, Egypt

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Misoprostol

Drug

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

Primary outcomes

  1. route of delivery vaginal or caesarean section.

    Time frame: 48 hours from the start of induction

    Partogram is used to access the progress of labour

Secondary outcomes

  1. maternal haemorrhage

    Time frame: 48 hours from the start of induction

    Calculating number of soaked pads

Sponsors and collaborators

Lead sponsor

Kasr El Aini Hospital

Other

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 2, 2016
Registry last updated
Oct 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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