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Completed

NCT Number: NCT04858945

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

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Hefei, Anhui, 240001, China

About this study

Education for teach-back group and control group During the trial, women from teach-back group and controlled group will receive three education sessions arranged by trained nursing supervisors who played the educator role. The first education session is 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. The topics discussed at the first session includ 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. 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. 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, a short online meeting will be arranged between one woman and one educator. During the meeting, the educator answer questions raised by the woman and give advices on the challenges and difficulties in postpartum recover and caring newborn faced by the woman. teach-back group and control group share same 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, women in teach-back group will be asked to use their own words to restate what was just learned and the educator assesses the patient's understanding of the subject, identifies misunderstandings, corrects the mistaken, and provides additional information if required until women can correctly restate what they were expected to learn.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Maternal Health Literacy

    Time frame: Change from Baseline PMHLS at postpartum 42 days

    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.

  2. Postpartum health behaviours

    Time frame: up to postpartum 42 days

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

  3. Maternal-infant health outcomes

    Time frame: up to postpartum 42 days

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

Sponsors and collaborators

Lead sponsor

Anhui Provincial Hospital

Other Gov

Collaborators

  • Aalto University

Registry information

Official study title

Using Teach Back to Improve Postpartum Maternal-infant Health Among Women With Limited Maternal Health Literacy: A Randomized, Controlled Study

Acronym: TB

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Apr 26, 2021
Registry last updated
Nov 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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