Teenage Pregnancies in Refugee and Migrant Adolescents on the Thai-Myanmar Border

March 13, 2017 updated by: University of Oxford

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Tak
      • Mae Sot, Tak, Thailand, 63110
        • Shoklo Malaria Research Unit

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

12 years to 20 years (ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The participant will be adolescent mothers and non-pregnant adolescent aged 12 - <20 years, adolescent men aged < 20 years and ANC staff.

Description

Inclusion Criteria:

Inclusion criteria for adolescent mothers (subgroup 1) are:

  • 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

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

Inclusion criteria for adolescent men (subgroup 3) are:

  • Aged <20 years
  • Males
  • Migrant or refugee status
  • Myanmar nationality
  • Able and willing to participate and give informed consent

Inclusion criteria for health staff (subgroup 4) are:

  • No age restrictions
  • Females or males
  • Migrant, refugee or non-migrant status
  • Any nationality
  • Able and willing to participate and give informed consent

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
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
up to 1 year
Descriptive summary of demographic, social and medical characteristics of study participants
Time Frame: up to 1 year
up to 1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Summary of antenatal clinic staff perceptions
Time Frame: up to 1 year
up to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oxford

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 21, 2016

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 21, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 7, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 14, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 13, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SMRU 1602

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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