The Value of an Extended Postnatal Program.

NCT05289102 | Completed

• 1 other identifier: Protocol ID:277301
• Study Type: interventional
• Target: 1,159
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum

Keywords

Postpartum period; Breast Feeding; Gynaecology; Birth; Contraception

Outcome Measures

Primary Outcomes (14)

• Satisfaction with visit after having two visits.

  In the intervention group; Satisfaction differences will be measured by using a five-grade scale where 1 stand for "Strongly disagree" and 5 Stands for "Strongly agree" in the questionnaire.

  7 weeks after delivery.

• Satisfaction with visit after having one visit.

  In the control group; Satisfaction differences will be measured by using a five-grade scale where 1 stand for "Strongly disagree" and 5 Stands for "Strongly agree" in the questionnaire.

  7 weeks after delivery.

• Breastfeeding after having two visits.

  In the intervention group;Change in lactating measured by questionnaires. The participants were asked to report their breastfeeding. The answering alternatives werefully-lactating, non-lactating and part lactating.

  7 weeks after delivery

• Breastfeeding after having one visit.

  In the control group;Change in lactating measured by questionnaires. The participants were asked to report their breastfeeding. The answering alternatives werefully-lactating, non-lactating and part lactating.

  7 weeks after delivery

• Breastfeeding continued in month for the intervention group.

  Lactating at one year follow-up vill be measured by a questionnaire for all participating women one year after delivery. Participants were asked to report if the were still breastfeeding or if stopped breastfeeding for how many month since delivery.

  1 year after delivery.

• Breastfeeding continued in month for the control group.

  Lactating at one year follow-up vill be measured by a questionnaire for all participating women one year after delivery. Participants were asked to report if the were still breastfeeding or if stopped breastfeeding for how many month since delivery.

  1 year after delivery.

• Opinion on the number and content of the visit after having two visits.

  Intervention group;The women were asked in the questionnaire to report if they were satisfied. The answering alternatives were "It is enough with one visit" "I would preferred to have two visits close to the delivery and one a little bit later" . For you who got one visit 7 weeks pospartum what had you preferred to talk about if you had a visit 3 weeks after delivery? (You may choose more than one alternative)? 1. The delivery 2. Breastfeeding 3. Gyneacological problems, 4.contraception 5. Other emergent problems after delivery.

  At 7 weeks after delivery.

• Opinion on the number and content of the visit after having one visit.

  Control group;The women were asked in the questionnaire to report if they were satisfied. The answering alternatives were "It is enough with one visit" "I would preferred to have two visits close to the delivery and one a little bit later" . For you who got one visit 7 weeks pospartum what had you preferred to talk about if you had a visit 3 weeks after delivery? (You may choose more than one alternative)? 1. The delivery 2. Breastfeeding 3. Gyneacological problems, 4.contraception 5. Other emergent problems after delivery.

  At 7 weeks after delivery.

• Contraceptive use after having two visits.

  Intervention group; Change in contraception use measured by a questionnaire. The questonnaire contains questions to answer regarding 1. prevalence of contraception, 2. contraceptive method used and 3. time for start of contraception

  7 weeks postpartum

• Contraceptive use after having one visit.

  Control group; Change in contraception use measured by a questionnaire. The questonnaire contains questions to answer regarding 1. prevalence of contraception, 2. contraceptive method used and 3. time for start of contraception

  7 weeks postpartum

• Contraceptive use and compliance with method used after having two visits.

  Intervention group;The participated women were asked about change in contraception method and pregnancies during the first year after delivery. The answering alternatives were 1. do you still use the same contraceptive method? 2. If not what method have you changed to? 3. Why did you changed or stopped using the method? 4. Have you been pregnant? 5. Are you pregnant now?

  1 year after delivery

• Contraceptive use and compliance with method used after having one visit.

  Control group;The participated women were asked about change in contraception method and pregnancies during the first year after delivery. The answering alternatives were 1. do you still use the same contraceptive method? 2. If not what method have you changed to? 3. Why did you changed or stopped using the method? 4. Have you been pregnant? 5. Are you pregnant now?

  1 year after delivery

• Seeking medical care postpartum after having two visits.

  Intervention group; Seeking medical care the first three month postpartum measured by the questionnaire one year after delivery. The women were asked to report if they had been seeking medical care and if answer Yes on this question they could report reason.

  1 year after delivery.

• Seeking medical care postpartum after having one visit.

  Control group; Seeking medical care the first three month post partum measured by the questionnaire one year after delivery. The women were asked to report if they had been seeking medical care and if answer Yes on this question they could report reason.

  1 year after delivery.

Study Arms (2)

Two postpartum visits.

EXPERIMENTAL

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.

Other: One postpartum visit.

One postpartum visit.

ACTIVE COMPARATOR

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.

Other: Two postpartum visits.

Interventions

Two postpartum visits. 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.

One postpartum visit.

One postpartum visit. 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.

Two postpartum visits.

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: A woman who deliver a child close to enrolment
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

Ingela Lindh

Västra Frölunda, 42147, Sweden

Location

MeSH Terms

Conditions

Breast Feeding

Condition Hierarchy (Ancestors)

Feeding Behavior; Behavior

Study Officials

• Ingela Lindh, PhD

  Department of Obstetrics and Gynaecology, Sahlgrenska University Hospital, Sweden

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: This is a non-blind, two-arm randomized controlled multi-center trial

Study Record Dates

• First Submitted: February 8, 2022
• First Posted: March 21, 2022
• Study Start: January 10, 2019
• Primary Completion: February 17, 2020
• Study Completion: March 28, 2021
• Last Updated: March 21, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)