Birth OutcomesNCT06431581
Effect of a Mobile Health Intervention on Birth Outcomes
A study testing mHealth intervention (educational video, SMS and reminder phone call) in people with Birth Outcomes, run by Kathmandu University School of Medical Sciences at 1 site in Nepal.
Trial summary
Globally, neonatal and infant mortality persist as challenging concerns, paralleled by a notable prevalence of low birth weight and preterm birth. Some of the factors contributing to these issues include poor maternal health and nutrition, maternal smoking, and insufficient maternal awareness. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Birth Outcomes
- What is being tested?
- mHealth intervention (educational video, SMS and reminder phone call)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 494 participants
- Where
- 1 siteNepal
- Study dates
- 9 Sep 2024to Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Pregnant women of age 18 years and above;
- Pregnant with 13 to 27 weeks of gestation;
- Planned to deliver a child at selected hospital;
- Pregnant women who use smart phone;
- Can read and understand Nepali language
Who cannot join
- Pregnant women with vision impairment and diagnosed learning difficulties
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Nepal1 site, 1 recruiting
- Recruiting
Bhawana Shrestha
Dhulikhel, Bagmati, 45210
Bhawana Shrestha, MSN, 977-9841748266, bhawanakoju@kusms.edu.np
Kunta Devi Pun, PhD, 977-9841239826, kunta.devi.pun@kusms.edu.np
About this study
Official title: Effect of a Mobile Health Intervention on Birth Outcomes in a Tertiary Healthcare Facility in Nepal
Globally, neonatal and infant mortality persist as challenging concerns, paralleled by a notable prevalence of low birth weight and preterm birth. Some of the factors contributing to these issues include poor maternal health and nutrition, maternal smoking, and insufficient maternal awareness. Despite global efforts to improve maternal, newborn, and child health, adverse birth outcomes remain significant challenges, particularly in low and middle-income countries (LMICs). A noteworthy observation is that not all pregnant women modify their behaviours for their and their baby's health due to lack of social support, fear and insecurity. Recognizing the potential for interventions during pregnancy to positively influence maternal, fetal, and neonatal health, this research underscores the role of Mobile Health (mHealth) technologies in leveraging information and communication technology for health service delivery.
Accordingly, the study aims to evaluate the effect of mobile health intervention on birth outcomes in Nepal. In the initial phase, a qualitative study will be conducted to explore the views, informational needs and preferences of pregnant women regarding utilization of mHealth intervention. These insights will inform the development of user-centred educational videos and tailored mHealth interventions for pregnant women.
Read more
A two-arm parallel randomized controlled trial will then assess the mHealth intervention's effect on the birth outcomes of the pregnant women attending the antenatal care clinic of selected hospital. The investigators will randomize pregnant women at gestational age 13-27 weeks into either a control group (who will receive standard care along with a control video and reminder phone call for follow-up) or an intervention group (who will receive standard care along with m-health intervention that includes educational video, short message service (SMS) and reminder phone call for follow up).
Follow-up will be done from the time of enrolment until the first 24 hours after childbirth, focusing on evaluating the effect of m-Health intervention on birth outcomes (birth weight and gestational age at delivery). Data collection will utilize a self-constructed semi-structured questionnaire, along with validated questionnaires. The collected data will be analysed using STATA 14, contributing valuable insights into the potential effect of mHealth intervention on birth outcomes.
Read the detailed description
To evaluate the effect of mobile health intervention on birth outcomes, the sequential exploratory research design will be used. In the initial phase, a qualitative study will be conducted. The researcher will employ purposive sampling to select pregnant women visiting antenatal care clinic of selected hospital. Written informed consent will be obtained from research participants. Focus group discussions will be conducted with pregnant women to explore their views, informational needs and preferences regarding utilization of mHealth intervention. An educational video will be developed based on the findings of the qualitative study. After the video is developed, it will be validated by both expert and user groups to ensure its relevance, accuracy, and suitability. Additionally, the acceptability of the intervention will be assessed. The researcher will ensure that the educational video is user-centred by involving both experts and end users (pregnant women) throughout the design and development process.
After development and finalization of tailored educational video, a randomized controlled trial will be conducted. Prior to data collection, the researcher will provide information regarding the study such as purpose of the study and assistance required to the health professionals of the antenatal OPD.
Phase 1: Recruitment, baseline data collection and randomization:
The head of the obstetrics and paediatric departments, as well as healthcare professionals at the antenatal care (ANC) clinics, will be informed about the study. Their active cooperation will be sought throughout the study duration. Pregnant women who are of 13 to 27 weeks of gestation and meet the specified inclusion criteria, while attending the antenatal clinic at selected hospital, will be provided with comprehensive information about the study. This information will cover the study's rationale, procedures, follow-up schedules and voluntary nature of their participation. Eligibility assessments for pregnant women will be conducted by the researcher. Those who expresses a willingness to participate will be asked to provide written informed consent. To ensure impartial allocation of participants to either the intervention or control group, a random sequence number will be generated by a statistician using a computer. These numbers will be securely sealed in envelopes and provided to the enrolled pregnant women. Subsequently, pregnant women who have agreed to participate will be randomized into either the intervention or control group, with a 1:1 ratio, based on the group specified within the sealed envelopes provided to them. The researcher or research assistant will collect baseline information and gather data related to the knowledge of "pregnancy care for a healthy birth" from the participants in both the intervention and control groups.
Phase 2: Delivery of the intervention:
Development of intervention guide: To maintain consistent and standardized delivery of the intervention to all participants, an intervention guide, SMS guide and telephone guide will be developed.
Intervention group: Participants in the intervention group will have access to the educational videos and will be exposed to the following sequence of events:
- During the baseline data collection phase, the initial educational video addressing "pregnancy care for a healthy birth" will be viewed by participants via a tablet in a separate designated setting.
- Subsequently, this video will be made available on their smartphones, and participants will be instructed to watch it multiple times during their pregnancy.
- Participants will receive reminder phone calls and SMS to encourage them to watch videos at least three more times after their initial viewing in the antenatal care clinic.
- To ensure continuous engagement, the researcher will maintain regular contact through phone call with intervention group participants, reminding them to view the videos every month from the time of enrolment as per the reminder schedule.
- Additionally, pregnant mothers will be explicitly instructed to discuss the video content solely with their immediate family members and refrain from sharing it with others.
Control group: In contrast, participants in the control group will receive usual standard care and will be allowed to view a control video. Participants will be contacted through phone calls to remind their follow-up visit.
Phase 3: Follow up
Participant assessment and follow-up: The participants from both the intervention and control groups will undergo a series of assessments and follow -up visits.
- Post intervention knowledge assessment: Following the intervention phase, both groups will be subjected to a post-intervention knowledge assessment. The overall knowledge of pregnancy care for healthy birth will be assessed approximately one month following the participants' initial viewing of the videos.
- Birth outcomes assessment: Both the intervention and control group participants will be followed up within the first 24 hours of their delivery to evaluate and record the birth outcomes.
- Conditions
- Birth Outcomes
- Being tested
- mHealth intervention (educational video, SMS and reminder phone call)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mHealth intervention (educational video, SMS and reminder phone call)Behavioural
Pregnant women meeting the inclusion criteria and assigned to the intervention group will receive mHealth intervention that includes a tailored educational video, SMS messages, and reminder phone calls for follow-up
| Study group | Role | What they receive |
|---|---|---|
| Intervention group (educational video, SMS and reminder phone call) | Experimental | An intervention group will receive standard care along with mHealth intervention that includes tailored educational video, SMS and reminder phone call for follow up Receives: Behavioral: mHealth intervention (educational video, SMS and reminder phone call) |
| Control Group (standard care, control video and reminder phone call for follow up) | No intervention | A control group will receive standard care along with a control video and reminder phone call for follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth weight
The birth weight of the newborns delivered from the participants will be measured in grams. The mean birth weight of the newborns in both the intervention group and the control group will be compared.
Measured: 2-2.5 years
Gestational age at delivery
The gestational age at delivery will be expressed in completed weeks of gestation. The mean gestational age at delivery will be compared between the intervention group and the control group.
Measured: 2-2.5 years
Secondary outcomes (1)
Knowledge on pregnancy care
Knowledge on pregnancy care for healthy birth will be assessed through validated knowledge related questionnaire. The mean score will be be calculated for both the intervention and the control group and then will be compared.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2024
- Study start9 Sep 2024
- Primary completionDec 2026 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Birth OutcomesStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 494 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kathmandu University School of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bhawana Shrestha, Kathmandu University School of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06431581
- Sponsor's protocol ID
- NHRC 42-2042
- Status last verified
- Jun 2026
- First submitted
- 14 May 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lassi ZS, Middleton PF, Crowther C, Bhutta ZA. Interventions to Improve Neonatal Health and Later Survival: An Overview of Systematic Reviews. EBioMedicine. 2015 May 31;2(8):985-1000. doi: 10.1016/j.ebiom.2015.05.023. eCollection 2015 Aug.
PubMed 26425706Khani Jeihooni A, Mohammadkhah F, Razmjouie F, Harsini PA, Sedghi Jahromi F. Effect of educational intervention based on health belief model on mothers monitoring growth of 6-12 months child with growth disorders. BMC Pediatr. 2022 Sep 23;22(1):561. doi: 10.1186/s12887-022-03593-8.
PubMed 36151526Lassi ZS, Mansoor T, Salam RA, Das JK, Bhutta ZA. Essential pre-pregnancy and pregnancy interventions for improved maternal, newborn and child health. Reprod Health. 2014;11 Suppl 1(Suppl 1):S2. doi: 10.1186/1742-4755-11-S1-S2. Epub 2014 Aug 21.
PubMed 25178042Taneja S, Chowdhury R, Dhabhai N, Mazumder S, Upadhyay RP, Sharma S, Dewan R, Mittal P, Chellani H, Bahl R, Bhan MK, Bhandari N; Women and Infants Integrated Growth Study (WINGS) Group. Impact of an integrated nutrition, health, water sanitation and hygiene, psychosocial care and support intervention package delivered during the pre- and peri-conception period and/or during pregnancy and early childhood on linear growth of infants in the first two years of life, birth outcomes and nutritional status of mothers: study protocol of a factorial, individually randomized controlled trial in India. Trials. 2020 Jan 31;21(1):127. doi: 10.1186/s13063-020-4059-z.
PubMed 32005294Toolan M, Barnard K, Lynch M, Maharjan N, Thapa M, Rai N, Lavender T, Larkin M, Caldwell DM, Burden C, Manandhar DS, Merriel A. A systematic review and narrative synthesis of antenatal interventions to improve maternal and neonatal health in Nepal. AJOG Glob Rep. 2022 Feb;2(1):100019. doi: 10.1016/j.xagr.2021.100019.
PubMed 35252905Park JJH, Harari O, Siden E, Zoratti M, Dron L, Zannat NE, Lester RT, Thorlund K, Mills EJ. Interventions to improve birth outcomes of pregnant women living in low- and middle-income countries: a systematic review and network meta-analysis. Gates Open Res. 2020 Sep 24;3:1657. doi: 10.12688/gatesopenres.13081.2. eCollection 2019.
PubMed 33134854
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Mobile Health Intervention on Birth Outcomes in a Tertiary Healthcare Facility in Nepal
- ClinicalTrials.gov ID
- NCT06431581
- Acronym / sponsor ID
- NHRC 42-2042
- Conditions
- Birth Outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 494 participants (estimated)
- Lead sponsor
- Kathmandu University School of Medical SciencesUniversity, hospital or other
- Study start
- 9 Sep 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 28 May 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.
Globally, neonatal and infant mortality persist as challenging concerns, paralleled by a notable prevalence of low birth weight and preterm birth. Some of the factors contributing to these issues include poor maternal health and nutrition, maternal smoking, and insufficient maternal awareness. Despite global efforts to improve maternal, newborn, and child health, adverse birth outcomes remain significant challenges, particularly in low and middle-income countries (LMICs). A noteworthy observation is that not all pregnant women modify their behaviours for their and their baby's health due to lack of social support, fear and insecurity. Recognizing the potential for interventions during pregnancy to positively influence maternal, fetal, and neonatal health, this research underscores the role of Mobile Health (mHealth) technologies in leveraging information and communication technology for health service delivery.
Accordingly, the study aims to evaluate the effect of mobile health intervention on birth outcomes in Nepal. In the initial phase, a qualitative study will be conducted to explore the views, informational needs and preferences of pregnant women regarding utilization of mHealth intervention. These insights will inform the development of user-centred educational videos and tailored mHealth interventions for pregnant women.
A two-arm parallel randomized controlled trial will then assess the mHealth intervention's effect on the birth outcomes of the pregnant women attending the antenatal care clinic of selected hospital. The investigators will randomize pregnant women at gestational age 13-27 weeks into either a control group (who will receive standard care along with a control video and reminder phone call for follow-up) or an intervention group (who will receive standard care along with m-health intervention that includes educational video, short message service (SMS) and reminder phone call for follow up).
Follow-up will be done from the time of enrolment until the first 24 hours after childbirth, focusing on evaluating the effect of m-Health intervention on birth outcomes (birth weight and gestational age at delivery). Data collection will utilize a self-constructed semi-structured questionnaire, along with validated questionnaires. The collected data will be analysed using STATA 14, contributing valuable insights into the potential effect of mHealth intervention on birth outcomes.
Detailed description
To evaluate the effect of mobile health intervention on birth outcomes, the sequential exploratory research design will be used. In the initial phase, a qualitative study will be conducted. The researcher will employ purposive sampling to select pregnant women visiting antenatal care clinic of selected hospital. Written informed consent will be obtained from research participants. Focus group discussions will be conducted with pregnant women to explore their views, informational needs and preferences regarding utilization of mHealth intervention. An educational video will be developed based on the findings of the qualitative study. After the video is developed, it will be validated by both expert and user groups to ensure its relevance, accuracy, and suitability. Additionally, the acceptability of the intervention will be assessed. The researcher will ensure that the educational video is user-centred by involving both experts and end users (pregnant women) throughout the design and development process.
After development and finalization of tailored educational video, a randomized controlled trial will be conducted. Prior to data collection, the researcher will provide information regarding the study such as purpose of the study and assistance required to the health professionals of the antenatal OPD.
Phase 1: Recruitment, baseline data collection and randomization:
The head of the obstetrics and paediatric departments, as well as healthcare professionals at the antenatal care (ANC) clinics, will be informed about the study. Their active cooperation will be sought throughout the study duration. Pregnant women who are of 13 to 27 weeks of gestation and meet the specified inclusion criteria, while attending the antenatal clinic at selected hospital, will be provided with comprehensive information about the study. This information will cover the study's rationale, procedures, follow-up schedules and voluntary nature of their participation. Eligibility assessments for pregnant women will be conducted by the researcher. Those who expresses a willingness to participate will be asked to provide written informed consent. To ensure impartial allocation of participants to either the intervention or control group, a random sequence number will be generated by a statistician using a computer. These numbers will be securely sealed in envelopes and provided to the enrolled pregnant women. Subsequently, pregnant women who have agreed to participate will be randomized into either the intervention or control group, with a 1:1 ratio, based on the group specified within the sealed envelopes provided to them. The researcher or research assistant will collect baseline information and gather data related to the knowledge of "pregnancy care for a healthy birth" from the participants in both the intervention and control groups.
Phase 2: Delivery of the intervention:
Development of intervention guide: To maintain consistent and standardized delivery of the intervention to all participants, an intervention guide, SMS guide and telephone guide will be developed.
Intervention group: Participants in the intervention group will have access to the educational videos and will be exposed to the following sequence of events:
- During the baseline data collection phase, the initial educational video addressing "pregnancy care for a healthy birth" will be viewed by participants via a tablet in a separate designated setting.
- Subsequently, this video will be made available on their smartphones, and participants will be instructed to watch it multiple times during their pregnancy.
- Participants will receive reminder phone calls and SMS to encourage them to watch videos at least three more times after their initial viewing in the antenatal care clinic.
- To ensure continuous engagement, the researcher will maintain regular contact through phone call with intervention group participants, reminding them to view the videos every month from the time of enrolment as per the reminder schedule.
- Additionally, pregnant mothers will be explicitly instructed to discuss the video content solely with their immediate family members and refrain from sharing it with others.
Control group: In contrast, participants in the control group will receive usual standard care and will be allowed to view a control video. Participants will be contacted through phone calls to remind their follow-up visit.
Phase 3: Follow up
Participant assessment and follow-up: The participants from both the intervention and control groups will undergo a series of assessments and follow -up visits.
- Post intervention knowledge assessment: Following the intervention phase, both groups will be subjected to a post-intervention knowledge assessment. The overall knowledge of pregnancy care for healthy birth will be assessed approximately one month following the participants' initial viewing of the videos.
- Birth outcomes assessment: Both the intervention and control group participants will be followed up within the first 24 hours of their delivery to evaluate and record the birth outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group (educational video, SMS and reminder phone call) | Experimental | Behavioral: mHealth intervention (educational video, SMS and reminder phone call)An intervention group will receive standard care along with mHealth intervention that includes tailored educational video, SMS and reminder phone call for follow up |
| Control Group (standard care, control video and reminder phone call for follow up) | No intervention | –A control group will receive standard care along with a control video and reminder phone call for follow-up |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant women of age 18 years and above;
- Pregnant with 13 to 27 weeks of gestation;
- Planned to deliver a child at selected hospital;
- Pregnant women who use smart phone;
- Can read and understand Nepali language
Key exclusion criteria (1 listed)
- Pregnant women with vision impairment and diagnosed learning difficulties
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 |
|---|---|---|
| mHealth intervention (educational video, SMS and reminder phone call)Pregnant women meeting the inclusion criteria and assigned to the intervention group will receive mHealth intervention that includes a tailored educational video, SMS messages, and reminder phone calls for follow-up | Behavioural | Intervention group (educational video, SMS and reminder phone call) |
Primary outcome
Birth weight
Time frame: 2-2.5 years
The birth weight of the newborns delivered from the participants will be measured in grams. The mean birth weight of the newborns in both the intervention group and the control group will be compared.
Gestational age at delivery
Time frame: 2-2.5 years
The gestational age at delivery will be expressed in completed weeks of gestation. The mean gestational age at delivery will be compared between the intervention group and the control group.
1 secondary outcome
Knowledge on pregnancy care
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 26425706Lassi ZS, Middleton PF, Crowther C, Bhutta ZA. Interventions to Improve Neonatal Health and Later Survival: An Overview of Systematic Reviews. EBioMedicine. 2015 May 31;2(8):985-1000. doi: 10.1016/j.ebiom.2015.05.023. eCollection 2015 Aug.
- Background: PubMed 36151526Khani Jeihooni A, Mohammadkhah F, Razmjouie F, Harsini PA, Sedghi Jahromi F. Effect of educational intervention based on health belief model on mothers monitoring growth of 6-12 months child with growth disorders. BMC Pediatr. 2022 Sep 23;22(1):561. doi: 10.1186/s12887-022-03593-8.
- Background: PubMed 25178042Lassi ZS, Mansoor T, Salam RA, Das JK, Bhutta ZA. Essential pre-pregnancy and pregnancy interventions for improved maternal, newborn and child health. Reprod Health. 2014;11 Suppl 1(Suppl 1):S2. doi: 10.1186/1742-4755-11-S1-S2. Epub 2014 Aug 21.
- Background: PubMed 32005294Taneja S, Chowdhury R, Dhabhai N, Mazumder S, Upadhyay RP, Sharma S, Dewan R, Mittal P, Chellani H, Bahl R, Bhan MK, Bhandari N; Women and Infants Integrated Growth Study (WINGS) Group. Impact of an integrated nutrition, health, water sanitation and hygiene, psychosocial care and support intervention package delivered during the pre- and peri-conception period and/or during pregnancy and early childhood on linear growth of infants in the first two years of life, birth outcomes and nutritional status of mothers: study protocol of a factorial, individually randomized controlled trial in India. Trials. 2020 Jan 31;21(1):127. doi: 10.1186/s13063-020-4059-z.
- Background: PubMed 35252905Toolan M, Barnard K, Lynch M, Maharjan N, Thapa M, Rai N, Lavender T, Larkin M, Caldwell DM, Burden C, Manandhar DS, Merriel A. A systematic review and narrative synthesis of antenatal interventions to improve maternal and neonatal health in Nepal. AJOG Glob Rep. 2022 Feb;2(1):100019. doi: 10.1016/j.xagr.2021.100019.
- Background: PubMed 33134854Park JJH, Harari O, Siden E, Zoratti M, Dron L, Zannat NE, Lester RT, Thorlund K, Mills EJ. Interventions to improve birth outcomes of pregnant women living in low- and middle-income countries: a systematic review and network meta-analysis. Gates Open Res. 2020 Sep 24;3:1657. doi: 10.12688/gatesopenres.13081.2. eCollection 2019.
- Pregnancy and Childbirth - Healthy People 2030 \| health.govLink provided by the sponsor.
- Lessons from digital technology-enabled health interventions implemented during the coronavirus pandemic to improve maternal and birth outcomes: a global scoping review. BMC Pregnancy Childbirth. 2023 Mar 20;23(1):195.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mHealth intervention (educational video, SMS and reminder phone call) in people with Birth Outcomes, run by Kathmandu University School of Medical Sciences 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 5 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: looking for participants now, as of the sponsor's last update on 24 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bhawana Shrestha, MSN (9779841748266, bhawanakoju@kusms.edu.np), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth weight (time frame: 2-2.5 years). The study lists 2 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 NCT06431581, which also lists 6 linked publications.
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 24 Jun 2026.