NCT02788305

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
288

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

June 2, 2016

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2017

Completed
Last Updated

October 16, 2017

Status Verified

October 1, 2017

Enrollment Period

1.1 years

First QC Date

May 20, 2016

Last Update Submit

October 13, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • route of delivery vaginal or caesarean section.

    Partogram is used to access the progress of labour

    48 hours from the start of induction

Secondary Outcomes (1)

  • maternal haemorrhage

    48 hours from the start of induction

Study Arms (2)

non obese

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

Drug: Misoprostol

obese

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

Drug: Misoprostol

Interventions

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

non obeseobese

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

144 pregnant women with BMI \>= 30 and 144 pregnant women with BMI \<30, post date \>= 41 wks, not in labor admitted in Kaselaini H for induction of labor.

You may qualify if:

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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr wl aini hospitals

Cairo, Greater Cairo, 11956, Egypt

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obesity

Interventions

Misoprostol

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Heba M Marie, M.D.

    KasrElaini Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer at kaselaini hospitals

Study Record Dates

First Submitted

May 20, 2016

First Posted

June 2, 2016

Study Start

May 1, 2016

Primary Completion

May 30, 2017

Study Completion

June 30, 2017

Last Updated

October 16, 2017

Record last verified: 2017-10

Locations