Pregnant WomenTBNCT04858945
Using Teach Back to Improve Postpartum Maternal-infant Health Among Women With Limited Maternal Health Literacy
A study testing Teach-back method in people with Pregnant Women, run by Anhui Provincial Hospital at 1 site in China.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnant Women
- What is being tested?
- Teach-back method
- Type of treatment
- Vaccines, Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteChina
- Study dates
- 17 May 2021to 12 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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 :
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
the First Affiliated Hospital of University of Science and Technology of China
Hefei, Anhui, 240001
About this study
Official title: Using Teach Back to Improve Postpartum Maternal-infant Health Among Women With Limited Maternal Health Literacy: A Randomized, Controlled Study
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.
Read the 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.
- Conditions
- Pregnant Women
- Being tested
- Teach-back method
- Keywords
- maternal, health literacy, Postpartum Period, Health, Infant, Educational Technology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teach-back methodBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Teach-back method |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: up to postpartum 42 days
Maternal-infant health outcomes
Postpartum infection,subinvolution of uterus,acute mastitis,postpartum constipation,overweight,diaper dermatitis
Measured: up to postpartum 42 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start17 May 2021
- Primary completion10 Aug 2021
- Study completion12 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pregnant WomenStudies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 258 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- Aalto University
- Responsible party
- Sponsor
- Investigators
- Guizhi Cheng, Study chair, Anhui Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04858945
- Sponsor's protocol ID
- CGZ-01
- Acronym
- TB
- Status last verified
- Oct 2021
- First submitted
- 14 Apr 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The dataset generated and analysed for this study is not publicly available due to the restrictions claimed in the document of the research permission and ethical approval. But the data are available from the ethics committee of the First Affiliated Hospital Ethics Committee of USTC for researchers who meet the criteria for access to confidential data. To request access to the data, please contact the ethics committee of the First Affiliated Hospital Ethics Committee of USTC or the main researcher Qianqian Ni.
Publications
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.
PubMed 36624440
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Teach Back to Improve Postpartum Maternal-infant Health Among Women With Limited Maternal Health Literacy: A Randomized, Controlled Study
- ClinicalTrials.gov ID
- NCT04858945
- Acronym / sponsor ID
- TB / CGZ-01
- Conditions
- Pregnant Women
- Keywords
- maternal, health literacy, Postpartum Period, Health, Infant, Educational Technology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 258 participants (actual)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Collaborators
- Aalto University
- Study start
- 17 May 2021 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 12 Sep 2021 (actual)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Teach-back group | Experimental | Behavioral: Teach-back methodThe 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. |
| Control group | Active comparator | Behavioral: Teach-back methodTeach-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Teach-back methodDuring 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. | Behavioural | Control group, Teach-back group |
Primary outcome
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.
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
Maternal-infant health outcomes
Time frame: up to postpartum 42 days
Postpartum infection,subinvolution of uterus,acute mastitis,postpartum constipation,overweight,diaper dermatitis
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Derived from this study: PubMed 36624440Cheng 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.
- Individual participant dataSharing planned: No. The dataset generated and analysed for this study is not publicly available due to the restrictions claimed in the document of the research permission and ethical approval. But the data are available from the ethics committee of the First Affiliated Hospital Ethics Committee of USTC for researchers who meet the criteria for access to confidential data. To request access to the data, please contact the ethics committee of the First Affiliated Hospital Ethics Committee of USTC or the main researcher Qianqian Ni.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guizhi Cheng study chair
Anhui Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teach-back method in people with Pregnant Women, run by Anhui Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Health Literacy (time frame: Change from Baseline PMHLS at postpartum 42 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04858945, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.