Clinical trial NCT05289102: The Value of an Extended Postnatal Program.
Official title: An Extended Postnatal Program: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum
Keywords: Postpartum period
Breast Feeding
Gynaecology
Birth
Contraception
Lead sponsor: Vastra Gotaland Region
Sponsor class: OTHER_GOV
First posted: 2022-03-21
Enrollment: 1159
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a non-blind, two-arm randomized controlled multi-center trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The objective was to study and evaluate earlier and extended postpartum care visits (week 3 and 7) compared to the current structure of one traditional visit 7 weeks postpartum.

In Sweden there is an organized system of antenatal and postnatal care based on local maternity clinics that are run by midwives who collaborate with obstetricians and surrounding hospitals. Pregnant women are regularly assessed by a midwife during their antenatal care. If complications occur, they are assessed by an obstetrician at the maternity clinic or at the nearest hospital. Postnatally a follow up visit to the same maternity clinic is offered usually about 6-12 weeks postpartum. Nowadays a healthy primigravid woman with a full-term pregnancy and a healthy child leaves the hospital within 6-24 hours postpartum. Many women experience the time between leaving the hospital until the postnatal follow up visit as too long. It is described that women missing early feedback regarding the experience of giving birth, breastfeeding, the transition of parenthood and sometimes physical examination.The eligible women enrolled were asked if they wanted to voluntarily participate in the trial about postpartum care.The women participating were recruited in pregnancy week 37 and offered to join, and if interested randomly divided into one of two groups. One control group who received a traditional postpartum care visit, that is one visit to a midwife 7 weeks postpartum, and one intervention group where the participating women were invited to two visits to the midwife; 3 weeks postpartum and then an additional visit 7 weeks postpartum. At the end of the visits both in the intervention group and in the control group the women completed a questionnaire given them via a Quick Response-code (QR-code) to fill in on their mobile phone. The questionnaire contained questions regarding delivery, breastfeeding, satisfaction with recieved care, evaluation of postpartum care offered, satisfaction with the visit and birth control.

The hypothesis is that two visits (week 3 and 7) will have an impact on womens health, wellbeing, satisfaction and contraceptive use postpartum.

Detailed description: Trial Design and Setting. This is a non-blind, two-arm randomized controlled multi-center trial taking place in six different maternity clinics in Gothenburg and Molndal, Sweden (maternity clinics Frolunda Torg, Molndal, Gibraltargatan, Linné, Gamlestan, Angered).

Enrollment was conducted between January 2019 and February 2020. Pregnant women attending prenatal care in one of the included maternity clinics were approached.The women participating were recruited in pregnancy week 37 and offered to join, and if interested randomly divided into one of two groups The information about the trial was given in written and orally. The eligible women also had the opportunity to ask further questions to their pregnancy caregiver and patient responsible midwife. The information comprised that the participants was not given any merits or demerits if participating, decline or withdraw during the study. Eligible women who agreed to participate then gave written informed consent to the study. The randomization occurred after eligibility and consent.

Participants were randomly assigned to one of the trial groups, intervention, or control group. The randomization procedure was compiled together with a statistician. The chosen randomization procedure was based on the participants date of birth. If the participant was born on an even date of birth, she was allocated to intervention group. If the participant had an uneven date of birth, she was allocated to the control group. No co-location or stratification used.

Intervention and control. All enrolled women in the intervention group were in connection with the inclusion given two pre-booked postpartum care visits, one early at 3 weeks postpartum, and one later at 7 weeks postpartum. The control group received one pre-booked appointment at 7 weeks postpartum according to the traditional care.

At the first visit after giving birth the participants in the intervention group (3 week) as well as in the control group (7 week) were given opportunity to discuss breastfeeding, birth relating questions, and help with potential gynaecological problems such as ruptures and bleeding. The women were also given information regarding fertility postpartum and offered contraceptive counseling. The second visit (7 week) out of two in the intervention group gave opportunity to follow up the first 3 week visit. In connection to all visits the participants received a questionnaire via QR-code to fill in on the participants mobile phone/or as a paper questionnaire.

Data Collection. All participants in the intervention group or in the control group filled in the questionnaire through their phone/paper questionnaire close to their visit at the antenatal clinic . To ensure confidentiality all participants received an individual 4-digit code to use when answering the questionnaires. The code key is kept only for research responsible. The source data were collected using the esMaker, a secure web-based design for surveys. The data containing information on baseline characteristics such as nationality, age, BMI, height, weight, method of birth and parity. Questions regarding satisfaction with received care, whether fully-lactating, non-lactating, part lactating. Also questions regarding the participants opinion/satisfaction on the number of visits they received in the study, if they would have wished fewer/additional/latter/prior visits in relation the time of giving birth.

The questionnaires also comprise questions regarding contraceptive use, method of contraception and timing for start of contraceptive use postpartum.

One year after delivery the women in both the intervention group and the control group had a follow-up questionnaire.

Sample Size. Calculated sample size of a minimum of (n=400) in each group to achieve 80% power at a significance level at 0.05 and to detect a 10% difference between the independent groups (intervention and control group). A p-value \<.05 was considered statistically significant.

Statistical Methods. Statistical analysis was performed using Statistical Analysis System (SAS) version 9.4 following a predetermined statistical analysis plan. Initial analyses assessed for the equivalency of study groups on baseline characteristics using Mantel-Haenszel Chi Square tests to compare proportions for categorical variables and Fisher exact test to compare means for continuous variables. Risk ratios and 95% confidence intervals.

Eligibility criteria: Inclusion Criteria:

* Attending patient for prenatal care at one of the included maternal clinics,
* During the recruitment period was in the 37th pregnancy week,
* Independent and fluent in English or Swedish

Exclusion Criteria:

* Age \>18.
* Not fluent in English or Swedish

Primary outcomes:
measure: Satisfaction with visit after having two visits.
timeFrame: 7 weeks after delivery.
measure: Satisfaction with visit after having one visit.
timeFrame: 7 weeks after delivery.
measure: Breastfeeding after having two visits.
timeFrame: 7 weeks after delivery
measure: Breastfeeding after having one visit.
timeFrame: 7 weeks after delivery
measure: Breastfeeding continued in month for the intervention group.
timeFrame: 1 year after delivery.
measure: Breastfeeding continued in month for the control group.
timeFrame: 1 year after delivery.
measure: Opinion on the number and content of the visit after having two visits.
timeFrame: At 7 weeks after delivery.
measure: Opinion on the number and content of the visit after having one visit.
timeFrame: At 7 weeks after delivery.
measure: Contraceptive use after having two visits.
timeFrame: 7 weeks postpartum
measure: Contraceptive use after having one visit.
timeFrame: 7 weeks postpartum
measure: Contraceptive use and compliance with method used after having two visits.
timeFrame: 1 year after delivery
measure: Contraceptive use and compliance with method used after having one visit.
timeFrame: 1 year after delivery
measure: Seeking medical care postpartum after having two visits.
timeFrame: 1 year after delivery.
measure: Seeking medical care postpartum after having one visit.
timeFrame: 1 year after delivery.
Secondary outcomes:
Other outcomes:
Locations:
city: Västra Frölunda
country: Sweden
facility: Ingela Lindh
Study officials:
affiliation: Department of Obstetrics and Gynaecology, Sahlgrenska University Hospital, Sweden
name: Ingela Lindh, PhD
role: PRINCIPAL_INVESTIGATOR
References: