- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06251440
Initial Experience of Transabdominal Fetal Reduction in Nepal
February 8, 2024 updated by: PRAJWAL DAHAL, Grande International Hospital, Nepal
Transabdominal Fetal Reduction in Higher Order Multiple Pregnancies - a Pioneer Study in Nepal
Multifetal pregnancies are common in in vitro fertilization.
Multifetal gestation increases maternal and fetal morbidity and mortality.
We perform fetal reduction in our hospital by intra-thoracic injection of potassium chloride.
This manuscript is description of our initial experience.
Study Overview
Detailed Description
Assisted reproductive technology and stimulated conception have led to an increase in the prevalence of high order multifetal pregnancies (MFPs) in recent times.
MFPs are associated with high maternal and fetal complications.
Fetal mortality and morbidity are due to complications of prematurity.
Prevalence of pregnancy induced hypertension, pre-eclampsia, eclampsia, antepartum hemorrhage, post-partum hemorrhage, gestational diabetes and difficult deliveries are more in mother with MFP.
Embryo/Fetal reduction in high order MFPs helps in prolongation of gestation.
Multifetal pregnancy reduction (MFPR) is secondary prevention of the risks associated with MFP.
Trans-abdominal intracardiac injection of KCl is a simple, safe and effective technique for MFPR.
We are among the first few centers in Nepal doing MFPR.
In this study, we are sharing our initial experience of the procedure.
Study Type
Observational
Enrollment (Actual)
108
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Bagmati
-
Kathmandu, Bagmati, Nepal, Nepal
- Prajwal Dahal
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Multifetal pregnancies referred from the obstetrics and gynecology department of our hospital, different other hospitals and in vitro fertilization (IVF) centers across the country underwent ultrasound-guided transabdominal embryo/ fetal reduction procedure between February 2018 to April 2023 in our department.
Description
Inclusion Criteria:
- pregnant females with multifetal gestation who opt to undergo fetal reduction
Exclusion Criteria:
- who do not give consent
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Transabdominal ultrasonography guided fetal reduction is safe and effective in first trimester
Time Frame: 4.5 years
|
To share initial experience of transabdominal multifetal pregnancy reduction (MFPR) in Nepal
|
4.5 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Sharma Poudel, MD, Grande International Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2018
Primary Completion (Actual)
April 30, 2023
Study Completion (Actual)
April 30, 2023
Study Registration Dates
First Submitted
January 31, 2024
First Submitted That Met QC Criteria
February 8, 2024
First Posted (Estimated)
February 9, 2024
Study Record Updates
Last Update Posted (Estimated)
February 9, 2024
Last Update Submitted That Met QC Criteria
February 8, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 20/2020
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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