NCT02356744

Brief Summary

Ultrasound follow up for 9 months pregnancy in women underwent baraitric surgery before and after 1 year of surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 2, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
12 months until next milestone

Study Start

First participant enrolled

February 2, 2016

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

March 7, 2018

Status Verified

March 1, 2018

Enrollment Period

2.9 years

First QC Date

February 2, 2015

Last Update Submit

March 6, 2018

Conditions

Keywords

Maternal outcomeFetal outcomebariatric surgeryThird Trimester

Outcome Measures

Primary Outcomes (1)

  • maternal outcome

    development of pregnancy complications as preeclampsia or gestational diabetes or postpartum complications as postpartum hemorrhage or puerperal sepsis

    though 9 months of pregnancy and 6 weeks postpartum

Secondary Outcomes (2)

  • Neonatal outcome

    2 weeks after birth

  • Route of delivery

    time of delivery

Study Arms (2)

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

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

Other: Ultrasound

Interventions

Ultrasound assessment of fetal growth, anomalies , liqour and placenta

surgery done less than 1 yearsurgery done more than 1 year

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women in third trimester after laparoscopic adjustable gastric banding done within last 1 year or earlier

You may qualify if:

  • Pregnant women in third trimester 2.after laparoscopic adjustable gastric banding done within last 1 year or earlier

You may not qualify if:

  • medical disorders affecting pregnancy as diabetes, hypertension, SLE

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kasr Alainy medical school

Cairo, 12151, Egypt

RECRUITING

MeSH Terms

Conditions

Pregnancy Complications

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Female Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Ahmed M Maged

    Kasr Alainy medical school

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aly Abdelhafiz

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant professor

Study Record Dates

First Submitted

February 2, 2015

First Posted

February 5, 2015

Study Start

February 2, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

March 7, 2018

Record last verified: 2018-03

Locations