In Vitro FertilizationNCT06251440
Initial Experience of Transabdominal Fetal Reduction in Nepal
An observational study of In Vitro Fertilization, run by Grande International Hospital, Nepal at 1 site in Nepal.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- In Vitro Fertilization
- What is being tested?
- Fetal Reduction
- Type of treatment
- Injection or infusion
- How many people
- 108 participants
- Where
- 1 siteNepal
- Study dates
- 1 Feb 2018to 30 Apr 2023
- 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 45 years
- Women only
- No healthy volunteers
- Adult
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.
Who may be able to join
- pregnant females with multifetal gestation who opt to undergo fetal reduction
Who cannot join
- who do not give consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- In Vitro Fertilization
- Being tested
- Fetal Reduction
- Keywords
- Fetal reduction, Multifetal gestation, In Vitro fertilization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal ReductionDrug
Also called Selective fetal reduction
Under ultrasound guidance, intracardiac injection of 0.2 to 3.0 ml of 15% weight/volume (2 miliequivalent/mililiter ) potassium chloride (KCl) was administered via transabdominal route
What is being measured
The primary outcome is the main question the study is designed to answer.
Transabdominal ultrasonography guided fetal reduction is safe and effective in first trimester
To share initial experience of transabdominal multifetal pregnancy reduction (MFPR) in Nepal
Measured: 4.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2024
- Study start1 Feb 2018
- Primary completion30 Apr 2023
- Study completion30 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for In Vitro FertilizationStudies 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
- Retrospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Grande International Hospital, Nepal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, PRAJWAL DAHAL, Grande International Hospital, Nepal
- Investigators
- Sharma Poudel, MD, Principal investigator, Grande International Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06251440
- Sponsor's protocol ID
- 20/2020
- Status last verified
- Feb 2024
- First submitted
- 31 Jan 2024
- Last updated
- 9 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transabdominal Fetal Reduction in Higher Order Multiple Pregnancies - a Pioneer Study in Nepal
- ClinicalTrials.gov ID
- NCT06251440
- Acronym / sponsor ID
- 20/2020
- Conditions
- In Vitro Fertilization
- Keywords
- Fetal reduction, Multifetal gestation, In Vitro fertilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Grande International Hospital, NepalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 30 Apr 2023 (actual)
- Study completion
- 30 Apr 2023 (actual)
- First posted
- 9 Feb 2024 (actual)
- 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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (1 listed)
- pregnant females with multifetal gestation who opt to undergo fetal reduction
Key exclusion criteria (1 listed)
- who do not give consent
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 |
|---|---|---|
| Fetal ReductionAlso: Selective fetal reductionUnder ultrasound guidance, intracardiac injection of 0.2 to 3.0 ml of 15% weight/volume (2 miliequivalent/mililiter ) potassium chloride (KCl) was administered via transabdominal route | Drug | – |
Primary outcome
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
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 9 Feb 2024.
- Individual participant dataSharing planned: No
Related trials for In Vitro Fertilization
RecruitingObservational study
International Pilot Study for Dual Non-invasive Assesment of Embryo Development
Infertility
RecruitingPhase 2
Ubiquinone vs. Ubiquinol Supplementation
IVF
Recruiting
Trigger Timing in Ovarian Stimulations
IVF Outcome
Active, not recruiting
Automation of the In Vitro Fertilization Laboratory
Infertility, ART
RecruitingPhase 4
Study of G-CSF for DOR in Patients Undergoing IVF
Diminished Ovarian Reserve, IVF
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.
Sharma Poudel, MD principal investigator
Grande International 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 In Vitro Fertilization, run by Grande International Hospital, Nepal at 1 site in Nepal.
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: finished, as of the sponsor's last update on 9 Feb 2024. 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 Nepal. 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?
Transabdominal ultrasonography guided fetal reduction is safe and effective in first trimester (time frame: 4.5 years). 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 9 Feb 2024.