UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049503 |
|---|---|
| Receipt number | R000056361 |
| Scientific Title | Effectiveness of family planning intervention among pregnant and postpartum women in Nepal: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2025/01/10 |
| Last modified on | 2023/09/25 11:42:30 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effectiveness of family planning intervention among pregnant and postpartum women in Nepal: A Randomized Controlled Trial
Acronym
Effectiveness of family planning intervention among pregnant and postpartum women in Nepal: A Randomized Controlled Trial
Scientific Title
Effectiveness of family planning intervention among pregnant and postpartum women in Nepal: A Randomized Controlled Trial
Scientific Title:Acronym
Effectiveness of family planning intervention among pregnant and postpartum women in Nepal: A Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Family planning interventions
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main objective of this studies to assess the effectiveness of family planning interventions among pregnant and postpartum women. To assess the unmet needs for family planning methods following child births in the study population.
Basic objectives2
Others
Basic objectives -Others
To assess the uptake of family planning methods among the different social-demographic factors.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To reduce unwanted pregnancies and unmet needs for family planning.
To increase in the uptake of modern contraceptives (modern contraceptive prevalence rate MCPR)
Key secondary outcomes
To limit the birth spacing to at least 12 months after postpartum and ultimately reduce neonatal and maternal mortality.
Base
Study type
Interventional
Study design
Basic design
Factorial
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
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
1.Provider Behavior Change Communication Refresher Training (PBCC-RT)-1 time.2 days training to the existing government health staff at different healthcare facilities.
2.Referral by Female community health volunteers (FCHVs) for family planning services-regular
3.Postpartum Family planning counselling tool-to utilise during counselling at home and healthcare facility-20 minutes
4. Home visits by family planning trained health personnel-3 time counselling to eligible women, their husbands and mother-in-laws. Sessions-30 minutes
5. Interventions at health care facilities- counselling about family planning methods during antenatal care visits, child immunisation and postnatal visits, side effects, informed choices-regular during outreach clinic on monthly basis
Counselling session- 20 minutes
Services to family planning insertion and removal-regular
Interventions/Control_2
For control arm regular health service at healthcare facility and FCHVs visits will be done.
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
| 15 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Female
Key inclusion criteria
Pregnant and within 6 months postpartum women Age >= 15 years and <=49 years old
Permanently residing in that area
Provide informed consent
Key exclusion criteria
Cognitive impairment like loss of memory and thinking capacity
Temporary migrants
Target sample size
240
Research contact person
Name of lead principal investigator
| 1st name | Minato |
| Middle name | |
| Last name | Nakazawa |
Organization
Kobe University
Division name
Graduate School of Health Sciences
Zip code
654-0142
Address
10-2 Tomogaoka 7-chrome Suma-ku, Kobe, Japan
TEL
+81-78-792-2555
minatonakazawa@gmail.com
Public contact
Name of contact person
| 1st name | Gita |
| Middle name | |
| Last name | Shrestha |
Organization
Kobe University
Division name
Graduate School of Health Scineces
Zip code
658-0015
Address
Motoyama-minami-machi, Higasi-Nada-ku, Kobe International House, Fukae, 206
TEL
070-4544-7708
Homepage URL
gitustha11@gmail.com
Sponsor or person
Institute
Kobe University
Institute
Department
Personal name
Funding Source
Organization
NEXT Generation Pioneering Scholarship for doctoral students, Career centre
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kobe University
Address
654-0142,10-2 Tomogaoka 7-chrome Suma-ku, Kobe, Japan
Tel
078-796-4504
kyoumu@ams.kobe-u.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2022 | Year | 12 | Month | 15 | Day |
Date of IRB
| 2022 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 02 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 11 | Month | 15 | Day |
Last modified on
| 2023 | Year | 09 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056361
