ObesityNCT02788305
Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy
An observational study of Obesity and Induced; Birth, run by Kasr El Aini Hospital at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obesity, Induced; Birth
- What is being tested?
- Misoprostol
- How many people
- 288 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2016to 30 Jun 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Pregnant woman.
- Post date >= 41 weeks.
- Absent onset of labor.
- Patient acceptance to join the study after signing an informed consent.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed 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.
- Conditions
- Obesity, Induced; Birth
- Being tested
- Misoprostol
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MisoprostolDrug
Misoprostol 25 micrograms every 6 hours will be given to obese and non obese groups
| Study group | Role | What they receive |
|---|---|---|
| non obese | BMI<30. Misoprostol is given for induction of labour according to Bishop score Receives: Drug: Misoprostol | |
| obese | BMI>30. Misoprostol is given for induction of labour according to Bishop score Receives: Drug: Misoprostol |
What is being measured
The primary outcome is the main question the study is designed to answer.
route of delivery vaginal or caesarean section.
Partogram is used to access the progress of labour
Measured: 48 hours from the start of induction
Secondary outcomes (1)
maternal haemorrhage
Calculating number of soaked pads
Measured: 48 hours from the start of induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2016 (estimated)
- Study start1 May 2016
- Primary completion30 May 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, heba mahmoud ibrahim marie, Kasr El Aini Hospital
- Investigators
- Heba M Marie, M.D., Principal investigator, KasrElaini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02788305
- Sponsor's protocol ID
- 9898
- Status last verified
- Oct 2017
- First submitted
- 20 May 2016
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 29610945
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy
- ClinicalTrials.gov ID
- NCT02788305
- Acronym / sponsor ID
- 9898
- Conditions
- Obesity, Induced; Birth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 2 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non obese | – | Drug: MisoprostolBMI<30. Misoprostol is given for induction of labour according to Bishop score |
| obese | – | Drug: MisoprostolBMI>30. Misoprostol is given for induction of labour according to Bishop score |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (4 listed)
- Pregnant woman.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MisoprostolMisoprostol 25 micrograms every 6 hours will be given to obese and non obese groups | Drug | non obese, obese |
Primary outcome
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
1 secondary outcome
maternal haemorrhage
Time frame: 48 hours from the start of induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2017.
- Derived from this study: PubMed 29610945Maged 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heba M Marie, M.D. principal investigator
KasrElaini Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity and Induced; Birth, run by Kasr El Aini Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
route of delivery vaginal or caesarean section. (time frame: 48 hours from the start of induction). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02788305, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2017.