Newborn Health ComplicationsNCT07804069
Encouraging Pregnant Women to Use Skilled Birth Attendants and Its Effects on Maternal and Newborn Health in Rural Bangladesh
A study testing Skilled Birth Attendant Encouragement Intervention in people with Newborn Health Complications and Maternal Health Complications, run by Hiroshima University at 1 site in Bangladesh.
Trial summary
The goal of this clinical trial is to learn whether encouraging pregnant women in rural Bangladesh to use a skilled birth attendant during childbirth can improve the health of mothers and newborns. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Newborn Health Complications, Maternal Health Complications
- What is being tested?
- Skilled Birth Attendant Encouragement Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Oct 2023to 4 Apr 2024
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Pregnant women residing in the selected study areas in rural Bangladesh
- Pregnant women approximately 5-7 months pregnant at enrollment
- Expected to give birth during the study follow-up period
- Provided informed consent to participate
Who cannot join
- No specific exclusion criteria were applied.
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
Community-Based Study Sites in Rangpur Sadar and Kaunia
Rangpur City, Rangpur Division
About this study
Official title: The Impact of Delivery at Hospital on Maternal and Newborn Health Outcome in Rural Bangladesh
The goal of this clinical trial is to learn whether encouraging pregnant women in rural Bangladesh to use a skilled birth attendant during childbirth can improve the health of mothers and newborns. The main questions it aims to answer are:
Does the encouragement increase the use of skilled birth attendants during childbirth? Does childbirth assisted by a skilled birth attendant lower health complications among mothers and newborns?
Researchers randomly assigned pregnant women to an encouragement group or a comparison group. Women in the encouragement group received a flyer with information about childbirth facilities, skilled birth attendants, and ambulance contact details. Researchers collected information after childbirth to assess maternal and newborn health complications.
- Being tested
- Skilled Birth Attendant Encouragement Intervention
- Keywords
- Skilled Birth Attendant, Maternal Health, Newborn Health, Maternal Complications, Newborn Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skilled Birth Attendant Encouragement InterventionBehavioural
Participants assigned to the encouragement group received a flyer containing information about childbirth facilities, skilled birth attendants, and ambulance contact information to encourage the use of health facilities for childbirth. The intervention was intended to encourage childbirth with the assistance of a skilled birth attendant.
| Study group | Role | What they receive |
|---|---|---|
| Encouragement Group | Experimental | Participants assigned to this group received an encouragement intervention promoting childbirth with the assistance of skilled birth attendants. The intervention included a flyer with information about childbirth facilities, skilled birth attendants, and ambulance contact information to encourage the use of health facilities for childbirth. Receives: Behavioral: Skilled Birth Attendant Encouragement Intervention |
| Control Group | No intervention | Participants assigned to this group did not receive the encouragement intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Health Complications Within 42 Days After Childbirth
Maternal health complications included postpartum hemorrhage, anemia, low blood pressure, high fever, and perineal tear. The occurrence of these complications was assessed after childbirth during the 42-day postpartum period. Each complication was recorded as a binary outcome (yes/no).
Measured: 0-3 days, 4-7 days, 8-13 days, 14-28 days, and 29-42 days postpartum
Newborns With Health Complications After Birth
Newborn health complications included birth asphyxia, newborn infection (including sepsis, jaundice, pneumonia, or high fever), and umbilical infection. Each complication was recorded as a binary outcome (yes/no) based on whether the complication occurred during the specified period after birth.
Measured: 0-3 days, 4-7 days, 8-13 days, 14-28 days, and 29-42 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start1 Oct 2023
- Primary completion4 Apr 2024
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Newborn Health ComplicationsStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hiroshima University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tania Parvin, Hiroshima University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804069
- Sponsor's protocol ID
- HR-LPES-001149
- Status last verified
- Aug 2026
- First submitted
- 27 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no formal plan to share individual participant data (IPD). Data may be available from the authors upon reasonable request, subject to ethical and data protection considerations.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Delivery at Hospital on Maternal and Newborn Health Outcome in Rural Bangladesh
- ClinicalTrials.gov ID
- NCT07804069
- Acronym / sponsor ID
- HR-LPES-001149
- Keywords
- Skilled Birth Attendant, Maternal Health, Newborn Health, Maternal Complications, Newborn Complications
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Hiroshima UniversityUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 4 Apr 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 4 Sep 2026 (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.
The goal of this clinical trial is to learn whether encouraging pregnant women in rural Bangladesh to use a skilled birth attendant during childbirth can improve the health of mothers and newborns. The main questions it aims to answer are:
Does the encouragement increase the use of skilled birth attendants during childbirth? Does childbirth assisted by a skilled birth attendant lower health complications among mothers and newborns?
Researchers randomly assigned pregnant women to an encouragement group or a comparison group. Women in the encouragement group received a flyer with information about childbirth facilities, skilled birth attendants, and ambulance contact details. Researchers collected information after childbirth to assess maternal and newborn health complications.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Encouragement Group | Experimental | Behavioral: Skilled Birth Attendant Encouragement InterventionParticipants assigned to this group received an encouragement intervention promoting childbirth with the assistance of skilled birth attendants. The intervention included a flyer with information about childbirth facilities, skilled birth attendants, and ambulance contact information to encourage the use of health facilities for childbirth. |
| Control Group | No intervention | –Participants assigned to this group did not receive the encouragement intervention. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Pregnant women residing in the selected study areas in rural Bangladesh
- Pregnant women approximately 5-7 months pregnant at enrollment
- Expected to give birth during the study follow-up period
- Provided informed consent to participate
Key exclusion criteria (1 listed)
- No specific exclusion criteria were applied.
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 |
|---|---|---|
| Skilled Birth Attendant Encouragement InterventionParticipants assigned to the encouragement group received a flyer containing information about childbirth facilities, skilled birth attendants, and ambulance contact information to encourage the use of health facilities for childbirth. The intervention was intended to encourage childbirth with the assistance of a skilled birth attendant. | Behavioural | Encouragement Group |
Primary outcome
Maternal Health Complications Within 42 Days After Childbirth
Time frame: 0-3 days, 4-7 days, 8-13 days, 14-28 days, and 29-42 days postpartum
Maternal health complications included postpartum hemorrhage, anemia, low blood pressure, high fever, and perineal tear. The occurrence of these complications was assessed after childbirth during the 42-day postpartum period. Each complication was recorded as a binary outcome (yes/no).
Newborns With Health Complications After Birth
Time frame: 0-3 days, 4-7 days, 8-13 days, 14-28 days, and 29-42 days after birth
Newborn health complications included birth asphyxia, newborn infection (including sepsis, jaundice, pneumonia, or high fever), and umbilical infection. Each complication was recorded as a binary outcome (yes/no) based on whether the complication occurred during the specified period after birth.
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 4 Sep 2026.
- Individual participant dataSharing planned: No. There is no formal plan to share individual participant data (IPD). Data may be available from the authors upon reasonable request, subject to ethical and data protection considerations.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skilled Birth Attendant Encouragement Intervention in people with Newborn Health Complications and Maternal Health Complications, run by Hiroshima University at 1 site in Bangladesh.
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 4 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 4 Sep 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 Bangladesh. 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?
Maternal Health Complications Within 42 Days After Childbirth (time frame: 0-3 days, 4-7 days, 8-13 days, 14-28 days, and 29-42 days postpartum). 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?
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 4 Sep 2026.