Obesity During Pregnancy in Clinical PracticeNCT02719873
The Impact of Maternal Obesity on Pregnancy Outcomes in El-Minia Locality
An observational study of Obesity During Pregnancy in Clinical Practice, run by Minia University at 1 site in Egypt.
Trial summary
A study will carried out over a period of one year , all obese pregnant women as diagnosed with BMI at the time of 1st ANC visit and before labor ,observation of events during both intra-partum \&postpartum periods it will be recorded.outcome will compared with normal other pregnant women Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Obesity During Pregnancy in Clinical Practice
- What is being tested?
- The impact of maternal obesity on pregnancy outcomes
- How many people
- 330 participants
- Where
- 1 siteEgypt
- Study dates
- Aug 2016to 14 Jul 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
- No healthy volunteers
- Adult
Study population: pregnant women with BMI more than 24 per meter square body surface area
Who may be able to join
- obese
- pregnant
- age 18 -40
- single viable cephalic foetus
Who cannot join
- less than 18 years more than 40 years associated medical disorders patient refusal non cephalic presentation
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of Maternal Obesity on Pregnancy Outcomes in El-Minia Locality a Case Control Survey Study
A study will carried out over a period of one year , all obese pregnant women as diagnosed with BMI at the time of 1st ANC visit and before labor ,observation of events during both intra-partum \&postpartum periods it will be recorded.outcome will compared with normal other pregnant women
Read the detailed description
It is known that obesity during pregnancy has drawbacks for both maternal and foetal outcome The aim of this study is to evaluate and measure the proportion of the adverse pregnancy outcomes attributable to maternal obesity and so reaching to recommendations in order to improve the outcomes and wellbeing of these women and their children.patient will be divided into two groups control group with normal BMI and study group and both compared as regard foetal and maternal outcome The assessed fetal variables will be: fetal birthweight \& incubators admission. Data will be retrieved from patients before labor and from investigator observation both intrapartum and postpartum.
- Being tested
- The impact of maternal obesity on pregnancy outcomes
- Keywords
- obesity , pregnancy , maternal and fetal outcome
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The impact of maternal obesity on pregnancy outcomesOther
observation of maternal obesity effect in foetal and maternal outcome
| Study group | Role | What they receive |
|---|---|---|
| control group | the group with normal BMI | |
| study group | The group with the BMI more than 24.9 kg per meter square to study the impact of maternal obesity in pregnancy outcome Receives: Other: The impact of maternal obesity on pregnancy outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mode of delivery
vaginal or Cesarean section
Measured: onset of labor till end
shoulder dystocia
arrest of shoulder more than one minute after delivery of the head
Measured: 1 minute after delivery of the head
foetal macrosomia
foetal weight at time of delivery more than 90th percentil
Measured: at time of labour or elective CS
Secondary outcomes (3)
postpartum hemorrhage
primary or secondary blood loss through birth canal more than 500cc
Measured: onset of labor and for 6 weeks after
postpatum maternal infection
postpartum signs of sepsis
Measured: end of labor and for 6weeks after
neonatal ICU admission
neonatal ICU admission
Measured: one month after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startAug 2016
- Primary completion14 Jul 2017
- Study completion14 Jul 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 Obesity During Pregnancy in Clinical PracticeStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Elkhateeb, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719873
- Sponsor's protocol ID
- MOI in pregnancy outcome
- Status last verified
- Jul 2017
- First submitted
- 21 Mar 2016
- Last updated
- 18 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Stuber TN, Kunzel EC, Zollner U, Rehn M, Wockel A, Honig A. Prevalence and Associated Risk Factors for Obesity During Pregnancy Over Time. Geburtshilfe Frauenheilkd. 2015 Sep;75(9):923-928. doi: 10.1055/s-0035-1557868.
PubMed 26500368
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Maternal Obesity on Pregnancy Outcomes in El-Minia Locality a Case Control Survey Study
- ClinicalTrials.gov ID
- NCT02719873
- Acronym / sponsor ID
- MOI in pregnancy outcome
- Keywords
- obesity , pregnancy , maternal and fetal outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- Aug 2016
- Primary completion
- 14 Jul 2017 (actual)
- Study completion
- 14 Jul 2017 (actual)
- First posted
- 25 Mar 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.
A study will carried out over a period of one year , all obese pregnant women as diagnosed with BMI at the time of 1st ANC visit and before labor ,observation of events during both intra-partum \&postpartum periods it will be recorded.outcome will compared with normal other pregnant women
Detailed description
It is known that obesity during pregnancy has drawbacks for both maternal and foetal outcome The aim of this study is to evaluate and measure the proportion of the adverse pregnancy outcomes attributable to maternal obesity and so reaching to recommendations in order to improve the outcomes and wellbeing of these women and their children.patient will be divided into two groups control group with normal BMI and study group and both compared as regard foetal and maternal outcome The assessed fetal variables will be: fetal birthweight \& incubators admission. Data will be retrieved from patients before labor and from investigator observation both intrapartum and postpartum.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | – | –the group with normal BMI |
| study group | – | Other: The impact of maternal obesity on pregnancy outcomesThe group with the BMI more than 24.9 kg per meter square to study the impact of maternal obesity in pregnancy outcome |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- pregnant women with BMI more than 24 per meter square body surface area
Key inclusion criteria (4 listed)
- obese
- pregnant
- age 18 -40
- single viable cephalic foetus
Key exclusion criteria (2 listed)
- less than 18 years more than 40 years associated medical disorders patient refusal non cephalic presentation
- -
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 |
|---|---|---|
| The impact of maternal obesity on pregnancy outcomesobservation of maternal obesity effect in foetal and maternal outcome | Other | study group |
Primary outcome
Mode of delivery
Time frame: onset of labor till end
vaginal or Cesarean section
shoulder dystocia
Time frame: 1 minute after delivery of the head
arrest of shoulder more than one minute after delivery of the head
foetal macrosomia
Time frame: at time of labour or elective CS
foetal weight at time of delivery more than 90th percentil
3 secondary outcomes
postpartum hemorrhage
Time frame: onset of labor and for 6 weeks after
postpatum maternal infection
Time frame: end of labor and for 6weeks after
neonatal ICU admission
Time frame: one month after delivery
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 18 Jul 2017.
- Results publication: PubMed 26500368Stuber TN, Kunzel EC, Zollner U, Rehn M, Wockel A, Honig A. Prevalence and Associated Risk Factors for Obesity During Pregnancy Over Time. Geburtshilfe Frauenheilkd. 2015 Sep;75(9):923-928. doi: 10.1055/s-0035-1557868.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 During Pregnancy in Clinical Practice, run by Minia University 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 2 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 18 Jul 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?
Mode of delivery (time frame: onset of labor till end). The study lists 3 primary outcomes in all. 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 NCT02719873, 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 18 Jul 2017.