UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061570 |
|---|---|
| Receipt number | R000060803 |
| Scientific Title | Birth doula support in a Mongolian maternity hospital: a quasi-experimental research design |
| Date of disclosure of the study information | 2026/05/14 |
| Last modified on | 2026/05/14 16:10:59 |
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Basic information
Public title
Promotion of respectful childbirth in Mongolia: an exploratory study of the effects of facility-based intervention in a large public maternity hospital
Acronym
Promotion of respectful childbirth in Mongolia
Scientific Title
Birth doula support in a Mongolian maternity hospital: a quasi-experimental research design
Scientific Title:Acronym
Birth doula support in a Mongolian maternity hospital
Region
| Asia(except Japan) |
Condition
Condition
Childbearing women
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To explore the effect of continuous support by midwifery students to a small group of labouring women on their childbirth experience and birth outcomes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Women's satisfaction and childbirth experience will be measured by the Mongolian version of the Childbirth Experience Questionnaire on the 1-2 postpartum day before hospital discharge.
Key secondary outcomes
birth outcomes; duration of the labour, oxytocin use and perineal status
Base
Study type
Interventional
Study design
Basic design
n-of-1
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
NO
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
In addition to usual clinical care during labor and delivery, women receive continuous physical and emotional care services from midwifery students trained in doula support. The doula support was provided over 6 weeks and 24/7 hours. The ratio of student doulas and women was 1:4 and 1:2 in labor and delivery rooms, respectively. Regardless of eligibility for the study, all women delivered during the intervention period at the hospital received the intervention.
Interventions/Control_2
usual clinical routine care
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
Uncomplicated singleton and cephalic presentation pregnancy, with spontaneous labor onset at gestational age 37 to 41 weeks, and women who were admitted during the active phase of the first stage of labor at cervical dilation of 4cm and more.
Key exclusion criteria
Multiple pregnancies, previous cesarean delivery, induced labor, cesarean delivery, severe pregnancy complication, severe maternal and newborn outcomes, preterm birth, low birth weight, and admission to ICU
Target sample size
840
Research contact person
Name of lead principal investigator
| 1st name | Ganchimeg |
| Middle name | |
| Last name | Togoobaatar |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-8533425
ganchiemg-t@gwe.md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Ganchimeg |
| Middle name | |
| Last name | Togoobaatar |
Organization
University of Tsukuba
Division name
Institute of Medicine
Zip code
305-8575
Address
1-1-1 Tennodai, Tsukuba, Ibaraki
TEL
029-853-3425
Homepage URL
https://www.md.tsukuba.ac.jp/mph/en/
ganchimeg-t@gwe.md.tsukuba.ac.jp
Sponsor or person
Institute
Institute of Medicine, University of Tsukuba
Institute
Department
Personal name
Ganchimeg Togoobaatar
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Tsukuba
Address
1-1-1 Tennodai, Tsukuna
Tel
029-853-3425
ganchimeg-t@gwe.md.tsukuba.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Amgalan Maternity Hospital (Ulaanbaatar, Mongolia)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 14 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
828
Results
Among 828 women, 420 were in the pre-intervention group and 408 in the intervention group. Demographic and obstetric characteristics were similar. Labor room stay was shorter in the intervention group for multiparous women and for those receiving oxytocin. CEQ scores were significantly higher after adjustment. Satisfaction >80% was also higher for labor, delivery, and postpartum care in the intervention group (91.9%, 92.2%, and 95.6%, respectively).
Results date posted
| 2026 | Year | 05 | Month | 14 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2026 | Year | 08 | Month | 01 | Day |
Baseline Characteristics
The mean age of study participants was 28.5 (sd5.3) with range between 18-42 years of age. There was no age difference between pre (28.7, sd 5.3)- and intervention group (28.4 sd5.2).
Nearly 99% of women were married. The majority of participants (63.9%) had a college or higher level of education, and 44.3% were unemployed. A comparison of demographic data between pre-intervention and intervention groups indicated no significant difference in age, marital status, educational level and employment
Participant flow
In total of 963 and 813 women were delivered pre- and intervention period between October 2019 and January 2020 at the maternity hospital. After exclusion of caesarean section delivery, induced labour, women who had pregnancy complication and adverse birth outcomes, there were 480 (49.8%) and 446 (54.9%) low obstetric risk women with spontaneous vaginal delivery in the pre- and intervention period. Further exclusion of women delivered within an hour, the final sample comprised 420 births in the pre-intervention group and 408 births in the intervention group; in total, 828 women participated in this study.
Adverse events
none
Outcome measures
The Childbirth Experience Questionnaire (CEQ) were selected to assess women`s childbirth experience and maternal satisfaction with care. Birth outcomes were use of oxytocin, length of labour, episiotomy or perineal tear.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 05 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 08 | Month | 28 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 03 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 28 | Day |
Date of closure to data entry
| 2020 | Year | 05 | Month | 16 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 10 | Day |
Date analysis concluded
| 2021 | Year | 06 | Month | 10 | Day |
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 14 | Day |
Last modified on
| 2026 | Year | 05 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060803
