The Value of an Extended Postnatal Program.

NCT ID: NCT05289102

Last Updated: 2022-03-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 1159 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-10
• Study Completion Date: 2021-03-28

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.

Conditions

Postpartum

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Two postpartum visits.

Group 1 serves as an intervention group (experimental). 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.

Group Type: EXPERIMENTAL

One postpartum visit.

Intervention Type: OTHER

Group 2 serves as a control group (active comparator). All enrolled women in the control group were in connection with the inclusion given one pre-booked postpartum care visit at 7 weeks postpartum according to the traditional postpartum care.

One postpartum visit.

Group 2 serves as a control group (active comparator). All enrolled women in the control group were in connection with the inclusion given one pre-booked postpartum care visit at 7 weeks postpartum according to the traditional postpartum care.

Group Type: ACTIVE_COMPARATOR

Two postpartum visits.

Intervention Type: OTHER

Group 1 serves as an intervention group (experimental). 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 and one later at 7 weeks postpartum.

Interventions

Two postpartum visits.

Group 1 serves as an intervention group (experimental). 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 and one later at 7 weeks postpartum.

Intervention Type: OTHER

One postpartum visit.

Group 2 serves as a control group (active comparator). All enrolled women in the control group were in connection with the inclusion given one pre-booked postpartum care visit at 7 weeks postpartum according to the traditional postpartum care.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Vastra Gotaland Region

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ingela Lindh, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Obstetrics and Gynaecology, Sahlgrenska University Hospital, Sweden

Locations

Ingela Lindh

Västra Frölunda, , Sweden

Countries

Sweden

Other Identifiers

Protocol ID:277301

Identifier Type: -

Identifier Source: org_study_id