Clinical trial NCT04858945: Using Teach Back to Improve Postpartum Maternal-infant Health Among Women With Limited Maternal Health Literacy
Official title: Using Teach Back to Improve Postpartum Maternal-infant Health Among Women With Limited Maternal Health Literacy: A Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pregnant Women
Keywords: maternal
health literacy
Postpartum Period
Health
Infant
Educational Technology
Lead sponsor: Anhui Provincial Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Aalto University
First posted: 2021-04-26
Enrollment: 258
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. over 18 years of age;
2. basically healthy and without being diagnosed with pregnancy complications;
3. with sufficient commands of communication in Chinese ;
4. at the pregnancy week between 37+0 and 41+6 but having no sign of labor or getting into the first stage of labor;
5. obtaining 27 or less points in the baseline measurement of MHL using perinatal maternal health literacy scale.

and Newborns who were :

1. born between 37 and 42 weeks of gestation age;
2. having a minimum apgar score of 8 after 5 minutes of being born;
3. with birth weights between 2500g and 4000g.

Exclusion Criteria:

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

Primary outcomes:
measure: Maternal Health Literacy
timeFrame: Change from Baseline PMHLS at postpartum 42 days
measure: Postpartum health behaviours
timeFrame: up to postpartum 42 days
measure: Maternal-infant health outcomes
timeFrame: up to postpartum 42 days
Secondary outcomes:
Other outcomes:
Locations:
city: Hefei
country: China
facility: the First Affiliated Hospital of University of Science and Technology of China
state: Anhui
Study officials:
affiliation: Anhui Provincial Hospital
name: Guizhi Cheng
role: STUDY_CHAIR
References: