Teenage PregnancyNCT02890628
Teenage Pregnancies in Refugee and Migrant Adolescents on the Thai-Myanmar Border
An observational study of Teenage Pregnancy, run by University of Oxford at 1 site in Thailand.
Trial summary
This study is to explore perceptions, experiences, beliefs and knowledge around teenage pregnancy, motherhood, sexual and reproductive health, family planning and support structures adolescent refugees and migrants and to identify demographic, social and medical characteristics of study participants. Read more about this study
- Who is it for?
- Ages 12 to 20 yearsHealthy volunteers can take part
- Conditions the study is for
- Teenage Pregnancy
- How many people
- 54 participants
- Where
- 1 siteThailand
- Study dates
- Sep 2016to 21 Sep 2016
- Phase
- Observational
- 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 12 to 20 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: The participant will be adolescent mothers and non-pregnant adolescent aged 12 - <20 years, adolescent men aged < 20 years and ANC staff.
Who may be able to join
- Aged 12 - <20 years
- Females
- Migrant or refugee status
- Myanmar nationality
- Any trimester of pregnancy or up to 12 month post partum
- Able and willing to participate and give informed consent
Show all 23Show fewer
- Inclusion criteria for non-pregnant female adolescents (subgroup 2) are:
- Aged <20 years
- Females
- Migrant or refugee status
- Myanmar nationality
- No past or current pregnancy
- Able and willing to participate and give informed consent
- Aged <20 years
- Males
- Migrant or refugee status
- Myanmar nationality
- Able and willing to participate and give informed consent
- No age restrictions
- Females or males
- Migrant, refugee or non-migrant status
- Any nationality
- Able and willing to participate and give informed consent
Who cannot join
- Any participant who is deemed by the researchers or health staff to be acutely physically or mentally unwell will be excluded.
- Participants who do not meet the age requirements, migration status or nationality requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Perceptions and Experiences of Teenage Pregnancies in Refugee and Migrant Adolescents on the Thai-Myanmar Border
This study is to explore perceptions, experiences, beliefs and knowledge around teenage pregnancy, motherhood, sexual and reproductive health, family planning and support structures adolescent refugees and migrants and to identify demographic, social and medical characteristics of study participants.
Read the detailed description
The study will be conducted as follows:
- 12-24 individual interviews with pregnant or postnatal adolescent girls (<20 years);
- 1 Focus group discussion of 6-10 non-pregnant female adolescents (<20 years);
- 1 Focus group discussion of 6-10 adolescent men (<20 years);
- 1 Focus group discussion of 6-10 Shoklo malaria research unit antenatal care staff;
Interviews and focus group discussion will be conducted with study participants who agree to participate in discussions about teenage pregnancy and motherhood, sexual and reproductive health. In-depth interviews and focus group discussion will be conducted in private meeting rooms in proximity to the antenatal clinic waiting areas. In-depth interviews and Focus group discussion will be co-facilitated by the principal investigator and a trained counsellor/midwife fluent in Karen, Burmese and English. Focus group discussion will be run separately for Burmese- and Karen-speaking participants and participants will be separated by subgroup. Focus group discussion will include 6-10 participants per group and for each focus group discussion to last between 45-60 minutes. Individual in-depth interviews will last approximately 60 minutes each.
- Conditions
- Teenage Pregnancy
- Keywords
- Thai-Myanmar border
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| pregnant/post-natal adolescents (<20 years) | 12-24 individual with pregnant or postnatal adolescent girls (<20 years) will be interviewed. | |
| non-pregnant female adolescents (<20 years) | 1 Focus group discussion of 6-10 non-pregnant female adolescents (<20 years) | |
| male adolescents (<20 year) | 1 Focus group discussion of 6-10 adolescent men (<20 years) | |
| SMRU health staff of antenatal clinics (ANC) | 1 Focus group discussion of 6-10 Shoklo Malaria Research Unit antenatal clinic staff |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thematic summary of adolescents' perceptions, experiences and beliefs in teenage pregnancy, motherhood, sexual and reproductive health, family planning and support structures adolescent refugees and migrants
Measured: up to 1 year
Descriptive summary of demographic, social and medical characteristics of study participants
Measured: up to 1 year
Secondary outcomes (1)
Summary of antenatal clinic staff perceptions
Measured: up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2016 (estimated)
- Study startSep 2016
- Primary completion21 Sep 2016
- Study completion21 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Teenage PregnancyStudies of the same condition, open and under way.
- More trials run by University of OxfordThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oxford
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02890628
- Sponsor's protocol ID
- SMRU 1602
- Status last verified
- Mar 2017
- First submitted
- 13 Jul 2016
- Last updated
- 14 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perceptions and Experiences of Teenage Pregnancies in Refugee and Migrant Adolescents on the Thai-Myanmar Border
- ClinicalTrials.gov ID
- NCT02890628
- Acronym / sponsor ID
- SMRU 1602
- Conditions
- Teenage Pregnancy
- Keywords
- Thai-Myanmar border
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- University of OxfordUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 21 Sep 2016 (actual)
- Study completion
- 21 Sep 2016 (actual)
- First posted
- 7 Sep 2016 (estimated)
- 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.
This study is to explore perceptions, experiences, beliefs and knowledge around teenage pregnancy, motherhood, sexual and reproductive health, family planning and support structures adolescent refugees and migrants and to identify demographic, social and medical characteristics of study participants.
Detailed description
The study will be conducted as follows:
- 12-24 individual interviews with pregnant or postnatal adolescent girls (<20 years);
- 1 Focus group discussion of 6-10 non-pregnant female adolescents (<20 years);
- 1 Focus group discussion of 6-10 adolescent men (<20 years);
- 1 Focus group discussion of 6-10 Shoklo malaria research unit antenatal care staff;
Interviews and focus group discussion will be conducted with study participants who agree to participate in discussions about teenage pregnancy and motherhood, sexual and reproductive health. In-depth interviews and focus group discussion will be conducted in private meeting rooms in proximity to the antenatal clinic waiting areas. In-depth interviews and Focus group discussion will be co-facilitated by the principal investigator and a trained counsellor/midwife fluent in Karen, Burmese and English. Focus group discussion will be run separately for Burmese- and Karen-speaking participants and participants will be separated by subgroup. Focus group discussion will include 6-10 participants per group and for each focus group discussion to last between 45-60 minutes. Individual in-depth interviews will last approximately 60 minutes each.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| pregnant/post-natal adolescents (<20 years) | – | –12-24 individual with pregnant or postnatal adolescent girls (<20 years) will be interviewed. |
| non-pregnant female adolescents (<20 years) | – | –1 Focus group discussion of 6-10 non-pregnant female adolescents (<20 years) |
| male adolescents (<20 year) | – | –1 Focus group discussion of 6-10 adolescent men (<20 years) |
| SMRU health staff of antenatal clinics (ANC) | – | –1 Focus group discussion of 6-10 Shoklo Malaria Research Unit antenatal clinic staff |
Who may qualify
- Ages
- 12 to 20 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- The participant will be adolescent mothers and non-pregnant adolescent aged 12 - <20 years, adolescent men aged < 20 years and ANC staff.
Key inclusion criteria (23 listed)
- Aged 12 - <20 years
- Females
- Migrant or refugee status
- Myanmar nationality
- Any trimester of pregnancy or up to 12 month post partum
Key exclusion criteria (2 listed)
- Any participant who is deemed by the researchers or health staff to be acutely physically or mentally unwell will be excluded.
- Participants who do not meet the age requirements, migration status or nationality requirements
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Thematic summary of adolescents' perceptions, experiences and beliefs in teenage pregnancy, motherhood, sexual and reproductive health, family planning and support structures adolescent refugees and migrants
Time frame: up to 1 year
Descriptive summary of demographic, social and medical characteristics of study participants
Time frame: up to 1 year
1 secondary outcome
Summary of antenatal clinic staff perceptions
Time frame: up to 1 year
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 14 Mar 2017.
- Individual participant dataSharing planned: Yes
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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?
An observational study of Teenage Pregnancy, run by University of Oxford at 1 site in Thailand.
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 23 inclusion and 2 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 14 Mar 2017. 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 Thailand. 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?
Thematic summary of adolescents' perceptions, experiences and beliefs in teenage pregnancy, motherhood, sexual and reproductive health, family planning and support structures adolescent refugees and migrants (time frame: up to 1 year). 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 14 Mar 2017.