UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027496 |
|---|---|
| Receipt number | R000031506 |
| Scientific Title | Evaluation of an Education Program on Obstetric Danger Signs and Coping Mechanisms Using Peer Educators among Pregnant Adolescents in Tanzania |
| Date of disclosure of the study information | 2017/05/25 |
| Last modified on | 2018/09/14 18:36:53 |
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Basic information
Public title
Evaluation of an Education Program on Obstetric Danger Signs and Coping Mechanisms Using Peer Educators among Pregnant Adolescents in Tanzania
Acronym
An Education Program for Pregnant Adolescents Using Peers in Tanzania: A Quasi-Experimental Study
Scientific Title
Evaluation of an Education Program on Obstetric Danger Signs and Coping Mechanisms Using Peer Educators among Pregnant Adolescents in Tanzania
Scientific Title:Acronym
An Education Program for Pregnant Adolescents Using Peers in Tanzania: A Quasi-Experimental Study
Region
| Africa |
Condition
Condition
Pregnancy
Classification by specialty
| Nursing |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
1)To determine the effectiveness of an education program on improving knowledge of obstetric danger signs among pregnant adolescents
Basic objectives2
Others
Basic objectives -Others
2)To assess the effect of peer support on strengthening coping mechanisms during pregnancy among pregnant adolescents
3)To assess the social support of pregnant adolescents
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.The intervention group would have higher knowledge of obstetric danger signs than the control group.
2.The intervention group will have good birth outcome compared to the control group
Key secondary outcomes
The intervention group would have strengthened coping mechanisms and social support compared to control group.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is 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
| Other |
Interventions/Control_1
Intervention group
Education program with two sessions lasting for two hours
Interventions/Control_2
Control group
No intervention receive usual 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
| 15 | years-old | <= |
Age-upper limit
| 19 | years-old | >= |
Gender
Female
Key inclusion criteria
1) aged between 15 to 19 years
2) has a first time pregnancy
3) can read and speak Swahili language
4) can access and use mobile phone
Key exclusion criteria
high risk pregnancy such as pre-eclampsia, gestational diabetes, and placenta previa
Target sample size
42
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Beatrice Mwilike |
Organization
St. Luke's International University
Division name
Department of Midwifery
Zip code
Address
Chibaken, Mihama-ku, Takasu, 4-4-2-108
TEL
050-3171-1935
beatricemwilike@yahoo.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Beatrice Mwilike |
Organization
St. Luke's International University
Division name
Department of Midwifery
Zip code
Address
Chibaken, Mihama-ku, Takasu, 4-4-2-108
TEL
050-3171-1935
Homepage URL
beatricemwilike@yahoo.com
Sponsor or person
Institute
St. Luke's International University
Japan Society for the Promotion of Science (JSPS) Core- to-Core Program Asia-Africa Science Platforms
Institute
Department
Personal name
Funding Source
Organization
St. Luke's International University
Japan Society for the Promotion of Science (JSPS) Core- to-Core Program Asia-Africa Science Platforms
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2017 | Year | 05 | Month | 25 | 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
A total of 50 participants were eligible to participate in the study among 84 who were enrolled. An intervention group included 26 participants and control group included 24 participants. Multiple imputations have resulted into analyzing 25 participants in the intervention group and 23 participants in the control group. Participants at baseline had a mean age of 18.00 (SD = 0.91) in the intervention group and 18.22 (SD = 0.79) in the control group. There were no significant differences among the baseline characteristics of intervention and control groups in age, marital status, education, occupation, number of ANC visits and gestational age.
There was a significant difference in scores of knowledge of obstetric danger signs at post-test for intervention (M = 9.60, SD = 0.71) and control (M = 5.12, SD = 3.61); t (46) = 3.05, p = 0.000. Also, there was a significant difference in scores at one month follow up test for intervention (M = 8.99, SD = 1.35) and control (M = 7.02, SD = 2.91); t (46) = 6.09, p = 0.006. There was a significant difference in scores of social support at pre-test for intervention (M = 37.16, SD = 6.46) and control (M = 42.83, SD = 4.70); t (46) = -3.45, p = 0.001. There was a significant difference in scores of social support at post-test for intervention (M = 36.72, SD = 6.77) and control (M = 43.03, SD = 5.72); t (46) = -3.47, p = 0.001. Also, there was a significant difference in scores at one month follow up test for intervention and control. There was no significant differences in the scores of coping mechanisms at post-test for the intervention group (M = 30.52, SD = 5.96) and control group (M = 31.46, SD = 5.21); t (46) = -0.58, p = 0.564. Furthermore, there was no significant difference in scores at one month follow up for intervention group and control group.
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
Open public recruiting
Date of protocol fixation
| 2017 | Year | 04 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 10 | Month | 20 | Day |
Date of closure to data entry
| 2017 | Year | 10 | Month | 20 | Day |
Date trial data considered complete
| 2017 | Year | 10 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 04 | Day |
Other
Other related information
The study demonstrated the potential of the peer-led education program in improving knowledge of danger signs among pregnant adolescents. However, it was difficult to ascertain the effect of the program on social support and coping mechanisms as there were no significant differences between the intervention and control group.
Management information
Registered date
| 2017 | Year | 05 | Month | 25 | Day |
Last modified on
| 2018 | Year | 09 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031506
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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