Using Teach Back to Improve Postpartum Maternal-infant Health Among Women With Limited Maternal Health Literacy

NCT04858945 | Completed

• 1 other identifier: CGZ-01
• Study Type: interventional
• Target: 258
• Locations: 1 country
• Sites: 1

Brief Summary

This is a randomized controlled trial study with two arms teach-back group vs. controlled group. We decided the assignment of the women to each group by tossing a coin (heads for the teach-back group and tails for the control group). The women were informed about receiving education during the trial, but they were not aware of the forms and techniques used in the trial, nor were they aware if they were assigned to the teach-back group or control group. For the first two education sessions, the women were grouped based on the time of their recruitment, i.e., being the first recruited, being the first grouped and being the first to receive education. The educators were numbered from 1 to 8 according to their work shifts and were assigned to education sessions in sequence and cycle. For the third education session, the educators were assigned to contact women based on the matching of their work schedules. The women could be grouped with different peers and met different educators during the trial. In this way, we could reduce the possible influence of educators and group peers on the results of the trial.

Conditions

Pregnant Women

Keywords

maternal; health literacy; Postpartum Period; Health; Infant; Educational Technology

Outcome Measures

Primary Outcomes (3)

• Maternal Health Literacy

  Perinatal Maternal Health Literacy Scale (PMHLS) To measure women's MHL at baseline (on the day when women just admitted to hospital) and 42 days postpartum, we employ perinatal maternal health literacy scale (PMHLS) that was brought up and validated in 2014 by a research team from Central South University in China \[54\]. PMHLS was developed by reference to the 55 knowledge and skill items defined in "Maternal and child health literacy - basic knowledge and skills", a national guidebook issued by China Ministry of Health in 2012 \[55\], which was also used by this study as the key source of developing educational interventions for both groups. PMHLS is comprised of 34 items with two response categories (correct =1, error/unknown=0). The range of total score is from 0 to 34, higher score indicating a higher level of maternal health literacy. The cut off score is 27, which means that women obtaining 27 points or less are deemed to be with low or limited maternal health literacy.

  Change from Baseline PMHLS at postpartum 42 days

• Postpartum health behaviours

  Exclusive breastfeeding 24 hours postpartum,exclusive breastfeeding 42 days postpartum,uptake at the 42 days postpartum check-up,complete uptake of recommended vaccines

  up to postpartum 42 days

• Maternal-infant health outcomes

  Postpartum infection,subinvolution of uterus,acute mastitis,postpartum constipation,overweight,diaper dermatitis

  up to postpartum 42 days

Study Arms (2)

Teach-back group

EXPERIMENTAL

The first education session will be arranged at the day or the following day of admission before delivery, with a group meeting involving three women and one educator. The main purpose of the first session is to help women understand and prepare for the labor. On the day of discharge after delivery, women will receive the second group education session hosted by an educator. The main purpose of the second session is to help women understand postpartum health issues, get to know the practice of postpartum recovery and learn newborn care skills. At two-week postpartum, a short online meeting will be arranged. During the meeting, the educator answers questions raised by the woman and gives advices on the challenges and difficulties in postpartum recover and caring newborn faced by the woman.

Behavioral: Teach-back method

Control group

ACTIVE COMPARATOR

Teach-back group and control group share some education content and communication methods, e.g. power-point presentation, educational video clips, live demonstration, information booklet, group discussion, and Q\&A, expect that before the end of each education session.

Behavioral: Teach-back method

Interventions

Teach-back method BEHAVIORAL

During the trial, women from teach-back group and controlled group will receive three education sessions The topics discussed at the first session included delivery mode, labor process and pain relief, newborn health and care (common health issues and care skills), perinatal die and excises, and perinatal psychological health. The topics discussed at the second session includ postpartum recovery, postpartum maternal health, perineum care (diet, oral care, perineal care, and hygiene), breastfeeding, postpartum blue and depression, neonatal care, neonatal screening tests, newborn vaccination and early child development. At two-week postpartum, the educator answers questions raised by the woman and gives advices on the challenges and difficulties in postpartum recover and caring newborn faced by the woman.

Control group; Teach-back group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• over 18 years of age;
• basically healthy and without being diagnosed with pregnancy complications;
• with sufficient commands of communication in Chinese ;
• at the pregnancy week between 37+0 and 41+6 but having no sign of labor or getting into the first stage of labor;
• obtaining 27 or less points in the baseline measurement of MHL using perinatal maternal health literacy scale.
• and Newborns who were :
• born between 37 and 42 weeks of gestation age;
• having a minimum apgar score of 8 after 5 minutes of being born;
• with birth weights between 2500g and 4000g.

You may not qualify if:

• women suffered from severe perinatal complications which required advanced special care e.g. transferring to intensive care unit (ICU)
• fetal congenital malformations were diagnosed during the trial
• women did not completed any of the required education sessions planned in the trial.

Sponsors & Collaborators

• Anhui Provincial Hospital: lead
• Aalto University: collaborator

Study Sites (1)

the First Affiliated Hospital of University of Science and Technology of China

Hefei, Anhui, 240001, China

Location

Related Publications (1)

• Cheng GZ, Chen A, Xin Y, Ni QQ. Using the teach-back method to improve postpartum maternal-infant health among women with limited maternal health literacy: a randomized controlled study. BMC Pregnancy Childbirth. 2023 Jan 9;23(1):13. doi: 10.1186/s12884-022-05302-w.

  PMID: 36624440 DERIVED

Study Officials

• Guizhi Cheng

  Anhui Provincial Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 26, 2021
• Study Start: May 17, 2021
• Primary Completion: August 10, 2021
• Study Completion: September 12, 2021
• Last Updated: November 2, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)