A trial exploring the feasibility of using telephone support (SMS and call) as a means of supporting young mothers (12-19 years) in Western Kenya soon after giving birth

• Register: ISRCTN
• Last refreshed on: 29 November 2021
• Main ID: ISRCTN15017499
• Date of registration: 17/07/2017
• Prospective Registration: No
• Primary sponsor: University of Mancester
• Public title: A trial exploring the feasibility of using telephone support (SMS and call) as a means of supporting young mothers (12-19 years) in Western Kenya soon after giving birth
• Scientific title: A pilot randomised controlled trial to explore Telephone Support Intervention as a means of supporting young mothers in the immediate postnatal period in Western Kenya
• Date of first enrolment: 11/05/2017
• Target sample size: 50
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN15017499
• Study type: Interventional
• Study design: Pilot randomised controlled trial mixed method (Prevention)
• Phase: Not Applicable

Countries of recruitment

Kenya

Contacts

• Name: Elijah Kirop

Key inclusion & exclusion criteria

Inclusion criteria:
1. All young postnatal mothers aged 12-19 years who have given birth to a singleton healthy baby at term at the respective centres (MTRH and KCRH)
2. Those for whom consent has been sought and/or those whose parents/guardians consent, and willing to participate in the study
3. Postnatal young mothers who own a mobile phone and are able to use common mobile telephone operation services
4. Ability to read telephone text to a basic level of understanding
5. Qualified midwives and/or nurse-midwives with more than one year experience working in maternity setting

Exclusion criteria:
1. Young postnatal mothers who have given birth through caesarean, or who had multiple pregnancies and/or whose babies developed birth complications or have congenital anomalies
2. Mothers who have no capacity to consent and/or participate (with severe mental disability/illness and/or learning disability. These groups of mothers will be excluded since they may require specific care due to their complex needs.


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Midwifery care - postnatal care of young mothers
Pregnancy and Childbirth
Midwifery care - postnatal care of young mothers

Intervention(s)

This pilot study seeks to assess the feasibility and acceptability of telephone support intervention in the postnatal care of young mothers. The sample size follows accepted guidelines for feasibility/pilot studies with a consideration of an attrition rate of 25%. Sample allocation to a group is performed using the SNOSE (sequentially numbered, opaque sealed envelopes) approach, with a set of random allocation numbers generated by a computer software program. The set of random numbers is performed by someone (biostatistician) who is independent of the intervention and data collection.

The mixed methods approach is applied as it is suitable in assessing feasibility studies as it may provide varied data that may be useful in informing future (definitive) trial. Eligible participants are duly informed of all the study procedures and their informed consent sought before being recruited. The intervention is developed using a Delphi technique, which is conducted involving midwives. The information sought is based on their professional expertise as midwives, and thus no personal data is collected. Moreover, since the information sought is practice-related, written consent is not be sought. However, a verbal consent is sought and the midwives are asked to voluntarily participate in the Delphi.

The trial seeks to test telephone support intervention (short message service-SMS; and a call) among young mothers (12-19 years) in western Kenya. The study participants are recruited and randomised to either the intervention or control groups during the first week postpartum (before discharge from maternity unit) at the respective study centres and followed up until the tenth week postpartum.

The usual care group receive

Primary Outcome(s)

1. Feasibility and acceptability of the intervention is measured using reviews of the quality data available that supports a main trial and qualitative interviews at ten weeks for young mothers and 12 weeks for midwives
2. Quality of data available that support a main trial by reviewing patient notes/files at baseline

Secondary Outcome(s)

1. Maternal social support is measured using the maternal social support at ten weeks postpartum
2. Maternal self-esteem is measured using the Rosenberg Self-esteem scale at ten weeks postpartum
3. Mother infant bonding is measured using the postpartum bonding instrument at ten weeks postpartum
4. Postnatal depression is measured using the Edinburgh Postnatal depression scale at ten weeks postpartum

Secondary ID(s)

Clinical trials ID...

Source(s) of Monetary Support

Lugina Africa Midwives Research Network (LAMRN)

Results

• Results available: Yes
• Date Completed: 30/12/2018