PostpartumNCT05289102
The Value of an Extended Postnatal Program.
A study testing Two postpartum visits. and One postpartum visit. in people with Postpartum, run by Vastra Gotaland Region at 1 site in Sweden.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postpartum
- What is being tested?
- Two postpartum visits. and One postpartum visit.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,159 participants
- Where
- 1 siteSweden
- Study dates
- 10 Jan 2019to 28 Mar 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age >18.
- Not fluent in English or Swedish
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Extended Postnatal Program: a Randomized Controlled Trial
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.
Read the 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
- Being tested
- Two postpartum visits., One postpartum visit.
- Keywords
- Postpartum period, Breast Feeding, Gynaecology, Birth, Contraception
- Medical subject headings
- Breast Feeding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Two postpartum visits. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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?
Measured: 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?
Measured: 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.
Measured: 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.
Measured: 1 year after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start10 Jan 2019
- Primary completion17 Feb 2020
- Study completion28 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostpartumStudies of the same condition, open and under way.
- More trials run by Vastra Gotaland RegionThe 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
- Model description
- This is a non-blind, two-arm randomized controlled multi-center trial
- Masking
- None (open label)
- Enrolment
- 1,159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vastra Gotaland Region
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Ingela Lindh, PhD, Principal investigator, Department of Obstetrics and Gynaecology, Sahlgrenska University Hospital, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05289102
- Sponsor's protocol ID
- Protocol ID:277301
- Status last verified
- Feb 2022
- First submitted
- 8 Feb 2022
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Extended Postnatal Program: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05289102
- Acronym / sponsor ID
- Protocol ID:277301
- Conditions
- Postpartum
- Keywords
- Postpartum period, Breast Feeding, Gynaecology, Birth, Contraception
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,159 participants (actual)
- Lead sponsor
- Vastra Gotaland RegionOther government
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 17 Feb 2020 (actual)
- Study completion
- 28 Mar 2021 (actual)
- First posted
- 21 Mar 2022 (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.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a non-blind, two-arm randomized controlled multi-center trial
| Arm | Type | Receives |
|---|---|---|
| Two postpartum visits. | Experimental | Other: One postpartum visit.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. |
| One postpartum visit. | Active comparator | Other: Two postpartum visits.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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Age >18.
- Not fluent in English or Swedish
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 |
|---|---|---|
| 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. | Other | One postpartum visit. |
| 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. | Other | Two postpartum visits. |
Primary outcome
Satisfaction with visit after having two visits.
Time frame: 7 weeks after delivery.
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.
Satisfaction with visit after having one visit.
Time frame: 7 weeks after delivery.
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.
Breastfeeding after having two visits.
Time frame: 7 weeks after delivery
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.
Breastfeeding after having one visit.
Time frame: 7 weeks after delivery
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.
Breastfeeding continued in month for the intervention group.
Time frame: 1 year after delivery.
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.
Breastfeeding continued in month for the control group.
Time frame: 1 year after delivery.
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.
Opinion on the number and content of the visit after having two visits.
Time frame: At 7 weeks after delivery.
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.
Opinion on the number and content of the visit after having one visit.
Time frame: At 7 weeks after delivery.
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.
Contraceptive use after having two visits.
Time frame: 7 weeks postpartum
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
Contraceptive use after having one visit.
Time frame: 7 weeks postpartum
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
Contraceptive use and compliance with method used after having two visits.
Time frame: 1 year after delivery
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?
Contraceptive use and compliance with method used after having one visit.
Time frame: 1 year after delivery
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?
Seeking medical care postpartum after having two visits.
Time frame: 1 year after delivery.
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.
Seeking medical care postpartum after having one visit.
Time frame: 1 year after delivery.
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.
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 21 Mar 2022.
- Individual participant dataSharing planned: No
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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.
Ingela Lindh, PhD principal investigator
Department of Obstetrics and Gynaecology, Sahlgrenska University Hospital, Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two postpartum visits. and One postpartum visit. in people with Postpartum, run by Vastra Gotaland Region at 1 site in Sweden.
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 3 inclusion and 2 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 21 Mar 2022. 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 Sweden. 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?
Satisfaction with visit after having two visits. (time frame: 7 weeks after delivery.). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2022.