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Obstetric Complication clinical trials

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NCT ID: NCT06325319 Not yet recruiting - Clinical trials for Obstetric Complication

Effect of Community Engagement Using M-Mama Champions

Start date: March 2024
Phase: N/A
Study type: Interventional

This study aims to determine the effectiveness of community engagement using M-MAMA Champions on awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women in Bahi, Dodoma. This is a community-based, cluster randomized controlled trial (cRCT) study, whereby 120 first and second-trimester pregnant women will be randomized at a ratio of 1:1 to the intervention and control groups. The intervention of sensitizing pregnant women on Obstetric danger signs, birth preparedness, and complication readiness by the empowered M-MAMA Champions to the intervention arm clusters will be done for one month, a two-hour session will be delivered every two weeks, using participatory learning and action model for women groups to test the effectiveness of M-MAMA Champions in improving literacy level of obstetric danger signs, birth preparedness and complication readiness and its practice among pregnant women. The following is the hypothesis being tested Null Hypothesis; There is no difference in improvement of awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women when community engagement is done using M-MAMA Champions compared to routine approaches. Alternative hypothesis; Community engagement using M-MAMA Champions to improve awareness of Obstetric Danger Signs, Birth Preparedness, and Complication Readiness among Pregnant Women is more effective than routine approaches. During each 2-hour session, five (5) women will gather up and discuss the obstetric danger signs, birth preparedness, and complication readiness with the assistance of the M-MAMA Champion as a facilitator. An approved brochure on the concerned subject will be used for sensitization. Baseline data will be collected before and after the intervention. The control arm won't receive any intervention.

NCT ID: NCT06273007 Recruiting - Stillbirth Clinical Trials

Improving Intrapartum Care for Saving Life at Birth in Ethiopia Through PartoMa Approach

PartoMa-Eth
Start date: June 1, 2023
Phase: N/A
Study type: Interventional

Overall Objective To introduce PartoMa approach (locally agreed and achievable intrapartum guidelines and a continual in-house training program) to Ethiopian context through continuous fetal heart rate (FHR) monitoring using MOYO device and co-creation of context specific intrapartum care guideline for improving decision making in intrapartum care in Eastern Ethiopia. Interventions 1. Locally agreed and achievable intrapartum guidelines 2. Low dose high frequency trainings (LDHF) 3. Partograph Overall Design A quasi-experimental pre-post study (PartoMa study) Setting Department of Obstetrics and Gynaecology Haramaya Hospital and Hiwot Fana University Hospital, Ethiopia. Population Laboring women delivering at the study site from February 2023 to March 2025 and their offspring, as well as health providers. Women and their offspring will be enrolled at/after onset of labour and followed until discharge. Endpoints The primary endpoint is perinatal mortality. For further description and secondary outcomes, please see below. Study Time Data collection from June 2023 to May 2025. Specific Objectives i. To assess FHR monitoring practice and use of obstetric guideline for decision making in Hiwot Fana University Hospital ii. To improve feto-maternal outcome through applying PartoMa approach in Hiwot Fana University Hospital. iii. To determine the feasibility, acceptability and sustainability of low-dose high frequency trainings and PartoMa seminars in Hiwot Fana University Hospital. iv. To document changes in pregnancy outcomes after the introduction of PartoMa approaches-seminars, low dose high frequency trainings, continuous FHR monitoring and tailored interventions-in Hiwot Fana University Hospital. Setting PartoMa Ethiopia will be implemented at Haramaya General Hospital and Hiwot Fana Comprehensive Specialized University Hospital, which are both busy maternity units in Eastern Ethiopia. Both are government hospitals with an annual delivery number of around 5,000.

NCT ID: NCT05942989 Not yet recruiting - Clinical trials for Obstetric Complication

The Effect of Reiki on Breastfeeding Self-efficacy, Pregnancy Complaints and Quality of Life

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

Despite the benefits of reiki application, no study has been found that examined the effects of reiki on breastfeeding self-efficacy, complaints during pregnancy and quality of life in pregnant women.

NCT ID: NCT05935371 Recruiting - Incontinence Clinical Trials

Consequences of Obstetric Anal Sphincter Injuries on Maternal Psychology and Relationship Experience

COMPaRE
Start date: October 26, 2023
Phase:
Study type: Observational

The aim is to ascertain whether sustaining an Obstetric Anal Sphincter Injury negatively impacts intra-family relationships and increases the risk of mental health conditions, including a women's perception of herself and her self-esteem. Research in this field will ensure that the correct care and adequate support is provided for these patients in the post-natal period and beyond. Recognition of these conditions and the provision of support for these patients may improve relationships, leading to improved parenting and positive outcomes for the child. It ought to be highlighted that the sequelae of obstetric anal sphincter injuries, including anal incontinence, may manifest later on in the female life course and therefore life-long accessibility to help and therapies is advocated for these women.

NCT ID: NCT05782296 Recruiting - Clinical trials for Obstetric Complication

Noninvasive Monitoring of Uterine Activity and Fetal Heart Rate

Start date: February 24, 2022
Phase:
Study type: Observational

A clinical study designed to validate the safety and performance of the TrueLaborâ„¢ device in monitoring labor vs. current standard of care.

NCT ID: NCT05704179 Completed - Quality of Life Clinical Trials

Evaluation of the Relationship Between Obstetric Comorbidity Index and Obstetric Quality of Recovery Score

Start date: January 20, 2023
Phase:
Study type: Observational

The goal of this prospective observational study is to learn about the correlation between obstetric comorbidity index and obstetric quality of recovery score in pregnant patients who undergo cesarean section. The main question aims to answer are: - Are there a correlation between the obstetric comorbidity index and the obstetric quality of recovery score? Can we predict the postoperative quality of recovery by calculating the obstetric comorbidity index before delivery? - What is the relationship between these scores with the type of anaesthesia given? Participants will answer an 11-question assessment scale to evaluate their recovery of quality in the postpartum period.

NCT ID: NCT05354284 Active, not recruiting - Clinical trials for Pregnancy Complications

Physical and Mental Health Among Sexual and Gender Minorities During Pregnancy, Birth and Postpartum

Start date: October 1, 2021
Phase:
Study type: Observational [Patient Registry]

Mental illness increases the risk of adverse birth outcomes (e.g. preterm birth), obstetric complications (e.g. emergency caesarean, birth injuries), and birth trauma. Sexual and gender minority (SGM) people on average experience increased mental illness. Therefore these risks are increased, with risk of prolonged ill health. Despite this, research in this area is scanty. The present project will provide important knowledge for improving the reproductive health of SGM people. The overall purpose of the project is to increase knowledge about physical and mental health (including fear of childbirth) during pregnancy and postpartum in SGM people. The project has the following aims: PART I 2017 - 2021Pilotstudy 1. To study fear of childbirth (FOC) among SGM people in Sweden; prevalence and factors associated to FOC 2. To investigate reasons to and consequences of FOC in SGM people PART II 2022-2027 Main study 3. To explore whether SGM people in Sweden have an increased incidence of mental illness during and after pregnancy, adverse birth outcomes, obstetric complications and birth trauma. 4. To explore how pre- and postnatal mental health, minority stress, and fear of childbirth correlate to birth outcomes, birth experience, and obstetric complications in SGM people. This is important for identifying specific risk factors for difficult births, and to explore postpartum health effects. 5. To explore in-depth how SGM people have experienced adverse birth outcomes, obstetric complications, and birth trauma, with a specific focus on minority stress and experiences of care during and after pregnancy and childbirth.

NCT ID: NCT05307393 Not yet recruiting - Clinical trials for Obstetric Complication

Maternal Positioning to Correct Fetal Occiput Posterior

Start date: January 1, 2024
Phase: N/A
Study type: Interventional

In evaluating a patient's ability to have a normal vaginal delivery, a practitioner must consider three factors. Commonly referred to as the three P's, these include Power (contractions), Passage (pelvis and soft tissue) and passenger (baby). Power can be controlled through induction and augmentation agents. Passage is determined by the women's body habitus. Passenger includes the baby's estimated fetal weight (EFW) and position. Throughout the history of obstetrics, the baby's position has been a factor that has acted as a strong predictor of a woman's ability to deliver vaginally. Several researchers have looked into the percentage of babies born in the Occiput Anterior (fetus facing down) vs. Occiput Posterior (fetus facing up aka "sunny side up") position. Studies have shown that the majority of babies are born in OA position and that the finding of an OA positioned baby is associated with a greater likelihood of a successful vaginal delivery. OP position is associated with higher risk of 3rd and 4th degree perineal lacerations, operative delivery (vacuum/forceps) and cesarean section. Therefore OP position poses a higher risk of morbidity to the patient and fetus. Multiple studies exist in the obstetrics and midwifery literature regarding maternal positioning to correct fetal malposition. Many of these studies have shown no significance and those that do have generated conflicting results and are consistently lacking in power. The aim of this prospective study is to determine if maternal positioning to either the side of fetal movement (contralateral/opposite to the fetal spine) or opposite of the side of fetal movement (ipsilateral to the fetal spine) during the first stage of labor is associated with correction of fetal OP to OA position. Upon admission to labor and delivery, following an initial ultrasound to confirm fetal OP position, women in this study will be randomly assigned to one of three groups; one control (Group A), and two experimental (Groups B and C) groups. Those assigned to Group A will be allowed to remain in any position they chose during their labor and delivery course. Group B will be placed in a dorsal recumbent, modified sims position on the side of fetal movement. Group C, will be placed in the same position but opposite that of which fetal kicks are felt. Subjects in the experimental group will be asked to remain in these positions throughout the majority of their labor and delivery course, up until the second stage of labor (10 cm dilated). They will be allowed to change positions for up to 10 min per hour for maternal comfort and any fetal resuscitation efforts. Anything longer than this will be considered a deviation from the protocol and will be documented as such, but all necessary intervention for fetal well-being will be allowed including changes in maternal position for longer than 10 minutes. Once a cervical dilation of 10cm is achieved all study interventions will be discontinued. Peanut balls and manual rotational maneuvers will not be allowed as they are considered confounding factors which may individually affect fetal position. Data will be collected from the hospital record. This data will include: maternal age, BMI, race, maternal medical complications, delivery type, laceration, fetal position at delivery, dilation on admission and weight of the baby.

NCT ID: NCT05079139 Completed - Clinical trials for Obstetric Complication

Musset's Surgical Technique: Evaluation of Long-term Results (LONGOMUSSET)

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

The surgical technique of Musset has shown its effectiveness for the cure of recto-vaginal fistulas. Recto-vaginal fistulas are mostly post-obstetric (88%). The objective of this study is to investigate the outcome of patients who underwent a Musset surgical technique, as well as their postoperative functional and anatomical results at a distance from the procedure.

NCT ID: NCT04903977 Completed - Clinical trials for Obstetric Complication

Detection of Obstetric Anal Sphincter Injuries With ONIRY Device

Start date: May 20, 2021
Phase: N/A
Study type: Interventional

The main purpose of the study is to confirm the clinical performance and safety of impedance spectroscopy using the ONIRY device for the detection of anal sphincter injuries arising from vaginal deliveries. The study group comprises 150 primiparous or multiparous women up to 8 weeks after the vaginal (spontaneous or assisted) delivery of singleton, live foetus, in any presentation, in gestational week 34 or more. The timeline for each subject in the study will be up to 5 weeks and will include 3 visits (V1-V3). All participants will be divided into 3 groups: A, B, C. Group A - subjects with no perineal tear signs, Group B - subjects with grade 1 or 2 per OASIS classification, and Group C - subjects with grade 3 or 4). The diagnostic performance will be evaluated in comparison to 3-D EUS (endoanal ultrasound) as a primary performance measure (primary endpoint).