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Postpartum clinical trials

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NCT ID: NCT06284278 Recruiting - Pregnancy Related Clinical Trials

Telehealth: Diaphragmatic vs. Pelvic Exercise in Postpartum Pregnancy-related Pelvic Girdle Pain

Start date: October 20, 2023
Phase: N/A
Study type: Interventional

The goal of this interventional study is to compare investigate the short-term and long-term effects of 8-week real-time telehealth-based diaphragmatic breathing exercise and pelvic stabilization exercise on pain, disability, and quality of life in postpartum women with pregnancy-related pelvic girdle pain.

NCT ID: NCT06168630 Recruiting - Postpartum Clinical Trials

Effects of Manual Lymph Drainage on Breast Engorgement in Postpartum Period.

Start date: April 5, 2023
Phase: N/A
Study type: Interventional

There have been many studies on the treatment of breast engorgement, there is a lack of research comparing the effectiveness of manual lymph drainage with massage. Therefore, this study will be a randomized controlled trial that aims to compare the effects of manual lymph drainage with massage on breast engorgement, pain, and self efficacy in the postpartum period.

NCT ID: NCT06133829 Recruiting - Pregnancy Clinical Trials

upREACH Perinatal Home Visitation Program

upREACH
Start date: January 22, 2024
Phase: N/A
Study type: Interventional

The purpose of this study is to assess the effectiveness of a new brief home visitation program delivered by non-nurse home visitors to 1) improve connections to community resources based on reported and assessed needs, 2) increase health self-efficacy, and 3) reduce maternal stress compared to a control group that receives standard care from an obstetric clinic. Secondary administrative data on infant birth outcomes, health care use during the first year of life (appointment adherence), and interaction with government services (such as public assistance or child welfare) will be compared between the groups. For the intervention group, we will secondarily also assess home visit compliance and satisfaction with the intervention. Participants will be asked to complete questionnaires that include questions about the participant, their pregnancy, their feelings, their family, and their use of social/community services. Half of the women in this study will be randomly offered free home visitation services and the other half of women in this study will receive standard services from the clinic. The intervention group will be offered at least two free home visits with a non-nurse home visitor. During these visits, the home visitor will provide them with resources and tools to help the participant prepare for their baby. All participants will complete a second round of electronic surveys at approximately 2 months postpartum. Intervention participant outcomes will be compared to a control group that receive standard care from an obstetric clinic.

NCT ID: NCT05849649 Recruiting - Pregnancy Related Clinical Trials

Mobile Application-based Exercise Intervention for Pregnant Women

Start date: August 1, 2023
Phase: N/A
Study type: Interventional

The overarching goal of this randomized controlled clinical trial is to test the efficacy of the mHealth app (BumptUp) for improving physical activity levels among pregnant and postpartum women in a rural setting. Secondary outcomes include weight status, dietary intake, glucose tolerance, blood pressure, and mental health. Specific Aim 1. Conduct an RCT (N=176) to assess the efficacy of the mHealth intervention for increasing physical activity levels during pregnancy (13-15, 23-25, and 35-37 weeks gestation) and postpartum (6 and 12 weeks) among women in a rural setting. Research Activities: The efficacy of BumptUp® will be determined by measuring physical activity levels (via accelerometry and surveys) between women who use the mobile app (intervention) and women who use only an educational brochure (attention control). Specific Aim 2: Assess the efficacy of the mHealth intervention on important obstetric outcomes including maternal weight status, dietary intake, glucose tolerance, blood pressure, and mental health. Research Activities: Maternal weight status, glucose tolerance, and blood pressure values will be obtained from patient charts. Dietary intake will be assessed via the National Cancer Institute Multifactor Screener. Maternal mental health status will be measured via The Edinberg Postpartum Depression Questionnaire, Center for Epidemiological Studies Depression Scale, and the State-Trait Anxiety Inventory.

NCT ID: NCT05696301 Recruiting - Cesarean Section Clinical Trials

Interest of Tecartherapy on a Painful Caesarean Section Scar: a Randomized Clinical Trial.

NOCEPAIN
Start date: July 4, 2023
Phase: N/A
Study type: Interventional

Cesareans are a frequent procedure in obstetrics and 15.4% (95% CI, 9.9-20.9%) of women with cesareans still have pain at 3 months after delivery. Currently, self-massage of the scar is recommended to them. Post-cesarean pain is associated with psychological disorders (including, e.g., anxiety, depression). Tecar therapy could improve the healing and pain associated with cesareans and therefore improve women's quality of life and their satisfaction. Objectives: The principal objective is to study the analgesic efficacy of tecar therapy for postoperative scar pain and/or discomfort at 3 month after cesarean delivery, by comparing it with sham tecar therapy. A randomized clinical trial with 2 parallel arms and single blinding, to study the efficacy of this medical device for therapeutic purposes. In both groups (randomization stratified as a first cesarean or repeat cesarean), the women will have the standard recommended treatment - manual self-massage of the scar. Women's instruction in this self-massage will be structured and identical for both groups, including the provision of an informational document describing how to perform this massage. The training will be provided immediately after randomization. - Description of the experimental group These women will receive Tecar through Winback® technology [CE medical 1984, Norma 60601-2, ISO9001, ISO13485. Class IIa medical device, CET (capacitative mode) 400 VA and RET (resistant mode) 100 Watts, weight 4 Kg)]. Each session will last for 20 minutes, and each individual will have 3 sessions over a period of 3 weeks. - Description of the control group ("sham treatment") The women will follow the same study design as the experimental group with activation of the portable placebo device identical to the active medical. Each session will last for 20 minutes, and each individual will have 3 sessions over a 3-week period. Principal endpoint: Visual analogic scale (VAS) for pain and/or discomfort at 3 months after delivery partum (with a ruler scored from 0 for no pain to 10 for the worst pain imaginable). Succinct description of the products: "Tecar" is an acronym for a type of therapy (transfer electrical capacitive and resistive). The Winback® is a portable, easy-to-handle noninvasive regenerator. This study will use only the instrumental mode and 4-cm electrodes. During each session, this electrode will be moved over the entire scar. We will use the following 3 modes: capacitive (CET), CET Dynamic, and resistant (RET). These allow us to standardize the treatment without taking into account either the thickness of the abdominal wall or the woman's morphology. Each session will take 20 minutes (CET for 4 min, CET Dynamic 6 min, RET 6 min and CET 4 min). The intensity of CET and RET will be adapted to each woman and the diathermy chosen according to the woman's threshold of comfort, to be determined by her at each session, in the experimental group. There will be 1 session a week for 3 weeks. Study plan and procedures: The eligible women will be identified by the physicians in both of the obstetrics departments participating in this study. The women will receive oral information as well as written information. If they are interested, they will be offered an inclusion visit, normally scheduled for one week later. After a second verification of the eligibility criteria at this inclusion meeting, reading the information form and signing the consent, they will be randomized into one of the two groups by random drawing. Each woman will have 3 sessions (1 session a week for 20 min for 3 consecutive weeks): active treatment by tecar therapy or sham/placebo tecar therapy. They will receive self-administered questionnaires at 3 and 6 months after delivery to be completed and returned.

NCT ID: NCT05663567 Recruiting - Breastfeeding Clinical Trials

TheEffect of a Solution-FocusedApproach on Breastfeeding

Start date: January 30, 2024
Phase: N/A
Study type: Interventional

The Effect of a Solution-FocusedApproach on Breastfeeding Self-efficacy: A RandomizedControlledStudy It is a single-blind, randomized controlled study with a pre-test post-test design. In this study, it is aimed to increase the psychosocial health levels of mothers in the postpartum period and to eliminate their concerns about breastfeeding and infant feeding, with a solution-oriented approach planned to be applied to mothers with low breastfeeding self-efficacy. In addition, it is thought that the results of the research will make an important contribution to the national literature. Question 1: Is a solution-oriented approach effective in increasing mothers' breastfeeding self-efficacy?

NCT ID: NCT05073224 Recruiting - Muscle Weakness Clinical Trials

Muscle Function After Childbirth

Start date: September 20, 2022
Phase: N/A
Study type: Interventional

This study will evaluate lower extremity and trunk neuromuscular control in 78 nulligravid and postpartum women. Participants will attend two experimental sessions, approximately 1 week apart, to assess neuromuscular function. Physical activity levels will also be assessed.

NCT ID: NCT05009433 Recruiting - Depression Clinical Trials

HIIT vs MICT During Pregnancy and Health and Birth Outcomes in Mothers and Children

HIIT MAMA
Start date: June 24, 2021
Phase: N/A
Study type: Interventional

Regular exercise during pregnancy and postpartum leads to health benefits for mother and child. Inactivity during pregnancy and after delivery is now treated as risky behavior. Physically active pregnant women significantly less often suffer from, among others, gestational diabetes, excessive weight gain, lipids disorders, hypertension, preeclampsia, depressive symptoms, functional and structural disorders, including stress urinary incontinence, back pain or diastasis recti abdominis (DRA). Prenatal physical activity reduces the risk of premature delivery and miscarriage, fetal macrosomia, complications in labor or the risk of metabolic disorders in children. High-intensity interval training (HIIT) has become one of the most popular trends in the fitness sector. The effectiveness of HIIT on a number of health indicators has been proven in various populations but limited data are available on HIIT during pregnancy. The first hypothesis is that the HIIT, implemented during pregnancy and after childbirth, as a stronger exercise stimulus, will have a better impact on selected biological and psychological parameters of mothers, as well as on selected health parameters of their children, compared to the MICT (moderate intensity continuous training). Therefore, it promises better preventive effects on pregnancy complications and ailments as well as non-communicable diseases occurring in these populations. In the second hypothesis, it was assumed that HIIT and MICT implemented during pregnancy and after childbirth, tailored to the specific needs of the perinatal period, will not differ in the effectiveness of maintaining normal functional parameters in women, including prevention of urinary incontinence, back pain, DRA, etc. Pregnant women who apply for the study will be divided into three groups: those attending the HIIT, MICT or educational programs. During the study, the participants will be under standard obstetric care. As comparative groups, non-pregnant women will be also recruited. The investigators will collect data on selected biological, functional and psychological parameters in the study women at each trimester of pregnancy, during the puerperium and one year after childbirth. The data from the medical documentation on the course of childbirth and the assessment of the new-born, as well as the results of preventive examinations in the study women's children aged one, two, four and six years will be also analyzed.

NCT ID: NCT04546100 Recruiting - Stress Clinical Trials

Maternal-Infant Exercise Program on Body Composition, Stress, Fatigue, and Attachment in Postpartum Women

Start date: August 4, 2020
Phase: N/A
Study type: Interventional

The aim of this study is to explore the effectiveness of the intervention measures of the "Maternal-Infant Exercise Program" to improve the postpartum women's body composition, stress, fatigue and parent-child attachment.

NCT ID: NCT03506204 Recruiting - Postpartum Clinical Trials

The Pelvic Floor Muscle Function in Chinese Primipara, a One-year Cohort Study

Start date: May 10, 2018
Phase:
Study type: Observational [Patient Registry]

It is a prospective cohort study.The primiparas in six geographic regions of China are recruited to observe the natural recovery of pelvic floor muscle. The pelvic floor muscle function is evaluated at 6 weeks,3 months and 12 months after delivery.