Pregnancy, ComplicationsNCT02356744
Maternal and Neonatal Outcome in Pregnant Women Before and After 1 Year Since Bariatric Operation
An observational study of Pregnancy, Complications, run by Cairo University at 1 site in Egypt.
Trial summary
Ultrasound follow up for 9 months pregnancy in women underwent baraitric surgery before and after 1 year of surgery. Read more about this study
- Who is it for?
- Ages 18 to 39 years, women only
- Conditions the study is for
- Pregnancy, Complications
- What is being tested?
- Ultrasound
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 2 Feb 2016to Jan 2019
- 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 39 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women in third trimester after laparoscopic adjustable gastric banding done within last 1 year or earlier
Who may be able to join
- 1.Pregnant women in third trimester 2.after laparoscopic adjustable gastric banding done within last 1 year or earlier
Who cannot join
- medical disorders affecting pregnancy as diabetes, hypertension, SLE
Trial locations and contacts
1 site in 1 country.
Aly Abdelhafiz contact
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy medical school
Cairo, 12151
Ahmed Maged, MD, 01005227404, prof.ahmedmaged@gmail.com
About this study
Official title: Comparison of Maternal and Neonatal Outcome Before and After 1 Year of Bariatric Surgery
Ultrasound follow up for 9 months pregnancy in women underwent baraitric surgery before and after 1 year of surgery.
Read the detailed description
Ultrasound follow up for 9 months pregnancy in women who had laparoscopic adjustable gastric banding done within last 1 year or earlier.
- Conditions
- Pregnancy, Complications
- Being tested
- Ultrasound
- Keywords
- Maternal outcome, Fetal outcome, bariatric surgery, Third Trimester
- Medical subject headings
- Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundOther
Ultrasound assessment of fetal growth, anomalies , liqour and placenta
| Study group | Role | What they receive |
|---|---|---|
| surgery done less than 1 year | Pregnant women who had bariatric surgery done within the last year before pregnancy. Ultrasound fetal monitoring,biophysical profile assessment and maternal follow up investigations and blood pressure monitoring through all pregnancy Receives: Other: Ultrasound | |
| surgery done more than 1 year | Pregnant women who had bariatric surgery done more than 1 year before pregnancy. Ultrasound fetal monitoring,biophysical profile assessment and maternal follow up investigations and blood pressure monitoring through all pregnancy Receives: Other: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
maternal outcome
development of pregnancy complications as preeclampsia or gestational diabetes or postpartum complications as postpartum hemorrhage or puerperal sepsis
Measured: though 9 months of pregnancy and 6 weeks postpartum
Secondary outcomes (2)
Neonatal outcome
Apgar score, neonatal ICU admission
Measured: 2 weeks after birth
Route of delivery
vaginal delivery or cesarean section and if cesarean its indications
Measured: time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study start2 Feb 2016
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy, ComplicationsStudies of the same condition, open and under way.
- More trials run by Cairo 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Maged, Cairo University
- Investigators
- Ahmed M Maged, Principal investigator, Kasr Alainy medical school
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356744
- Sponsor's protocol ID
- 126
- Status last verified
- Mar 2018
- First submitted
- 2 Feb 2015
- Last updated
- 7 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Maternal and Neonatal Outcome Before and After 1 Year of Bariatric Surgery
- ClinicalTrials.gov ID
- NCT02356744
- Acronym / sponsor ID
- 126
- Conditions
- Pregnancy, Complications
- Keywords
- Maternal outcome, Fetal outcome, bariatric surgery, Third Trimester
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 2 Feb 2016 (actual)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 5 Feb 2015 (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.
Ultrasound follow up for 9 months pregnancy in women underwent baraitric surgery before and after 1 year of surgery.
Detailed description
Ultrasound follow up for 9 months pregnancy in women who had laparoscopic adjustable gastric banding done within last 1 year or earlier.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| surgery done less than 1 year | – | Other: UltrasoundPregnant women who had bariatric surgery done within the last year before pregnancy. Ultrasound fetal monitoring,biophysical profile assessment and maternal follow up investigations and blood pressure monitoring through all pregnancy |
| surgery done more than 1 year | – | Other: UltrasoundPregnant women who had bariatric surgery done more than 1 year before pregnancy. Ultrasound fetal monitoring,biophysical profile assessment and maternal follow up investigations and blood pressure monitoring through all pregnancy |
Who may qualify
- Ages
- 18 to 39 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women in third trimester after laparoscopic adjustable gastric banding done within last 1 year or earlier
Key inclusion criteria (1 listed)
- 1.Pregnant women in third trimester 2.after laparoscopic adjustable gastric banding done within last 1 year or earlier
Key exclusion criteria (1 listed)
- medical disorders affecting pregnancy as diabetes, hypertension, SLE
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 |
|---|---|---|
| UltrasoundUltrasound assessment of fetal growth, anomalies , liqour and placenta | Other | surgery done less than 1 year, surgery done more than 1 year |
Primary outcome
maternal outcome
Time frame: though 9 months of pregnancy and 6 weeks postpartum
development of pregnancy complications as preeclampsia or gestational diabetes or postpartum complications as postpartum hemorrhage or puerperal sepsis
2 secondary outcomes
Neonatal outcome
Time frame: 2 weeks after birth
Route of delivery
Time frame: time of delivery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2018.
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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.
Aly Abdelhafiz contact
Ahmed M Maged principal investigator
Kasr Alainy medical school
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 Pregnancy, Complications, run by Cairo 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 7 Mar 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed M Maged (01005227404, prof.ahmedmaged@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
maternal outcome (time frame: though 9 months of pregnancy and 6 weeks postpartum). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2018.