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Postpartum clinical trials

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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: NCT05655364 Completed - Breastfeeding Clinical Trials

Development of a Breastfeeding Supportive Mobile Application

Start date: September 5, 2022
Phase: N/A
Study type: Interventional

This work; The aim of this study was to develop a breastfeeding-supporting mobile application and to determine the effect of this application on breastfeeding self-efficacy and outcomes of primiparous. The research is planned to be carried out in two stages. In the first phase of the research, a mobile breastfeeding application based on Breastfeeding Self-Efficacy Theory will be developed. In the second phase of the study, a single-blind randomized pre-test-post-test control group intervention study design will be used to examine the effect of this developed application on breastfeeding self-efficacy and outcomes of primiparous. The main questions it aims to answer are: 1. Does the breastfeeding-supporting mobile application based on the Breastfeeding-Self-Efficacy Theory change the breastfeeding-self-efficacy of women? 2. Does a breastfeeding support mobile application based on the Breastfeeding-Self-Efficacy Theory change the rate of women starting breastfeeding within the first hour after birth? 3. Does a breastfeeding-supporting mobile application based on the Breastfeeding-Self-Efficacy Theory change women's time to breastfeed alone? 4. Does a breastfeeding support mobile application based on the Breastfeeding-Self-Efficacy Theory change the breastfeeding duration of women?

NCT ID: NCT05537259 Active, not recruiting - Pregnancy Clinical Trials

BUMPP: A Study to Better Understand Mood During the Perinatal Period

BUMPP
Start date: June 27, 2022
Phase:
Study type: Observational

The overall goal of the BUMPP study is to improve our understanding of a range of moods, feelings, and thoughts that women can experience during pregnancy and soon after they give birth. This study will examine how these moods, feelings, and thoughts are related to changes in hormonal and immune health that women experience during and after pregnancy, and to mother-baby relationships and infant development in the early postpartum months.

NCT ID: NCT05433818 Completed - Breastfeeding Clinical Trials

The Effect of Breastfeeding Education and Skin-to-Skin Contact on Breastfeeding Efficiency and Maternal Attachment

Start date: January 15, 2022
Phase: N/A
Study type: Interventional

Objective: The study aimed to compare the effects of breastfeeding education and skin-to-skin contact on breastfeeding efficiency and maternal attachment. Design: This study was planned as a three-group randomized controlled study. Setting and participants: This study will conduct with 92 women in a delivery room in Turkey between October 2021 and May 2022. Methods: The study consists of continuous early skin-to-skin contact (SSC; Group A), breastfeeding education (Group B), and control groups (Group C). Group A received SSC education and Group B received structured breastfeeding education.

NCT ID: NCT05397899 Completed - Postpartum Clinical Trials

Abdominal Hypopressive Technique on Postpartum Low Back Pain

Start date: June 1, 2022
Phase: N/A
Study type: Interventional

Postpartum Low back pain (PP-LBP) is more common and can lead to limitations to women's daily activity. Pregnancy related low back pain has been reported to occur in 55% to 78% women worldwide.This study is planned to determine the effects of abdominal hypopressive technique on postpartum low back pain, mobility and disability.

NCT ID: NCT05289102 Completed - Postpartum Clinical Trials

The Value of an Extended Postnatal Program.

Start date: January 10, 2019
Phase: N/A
Study type: Interventional

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.

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: NCT05021302 Completed - Clinical trials for Stress Urinary Incontinence

Differences in the Effectiveness of Electromagnetic Stimulation Therapy and Kegel Exercises Based on Compliance, Subjective - Objective Symptoms and Pelvic Floor Muscle Strength in Postpartum Stress Urinary Incontinence

Start date: March 1, 2020
Phase: N/A
Study type: Interventional

Electromagnetic stimulation is a new modality and alternative in women with urinary incontinence (UI). However, there was not much evidence that compares the use of electromagnetic stimulation to Kegel Exercises in post-partum stress urinary incontinence (SUI). We evaluate the compliance rate, effectiveness (UDI-6 and 1-hour pad test), and pelvic muscle strength of electromagnetic stimulation on stress urinary incontinence compared with Kegel pelvic floor muscle exercises in post-partum women as conservative therapy. This study was a single-blind randomized trial in postpartum women diagnosed with stress urinary incontinence who came to YPK Mandiri Hospital. We recruited 40 Patients and were randomized into two groups, the electromagnetic stimulation (n=20) and Kegel exercises (n=20). The electromagnetic stimulation procedure was done three times a week for five weeks, and the Kegel exercises group will be instructed to do the exercises every day for eight weeks. Our primary objective is to measure compliance, symptom reduction (using the UDI-6 questionnaire and the 1-hour pad test), and pelvic floor muscle strength.

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.