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Pregnancy Related clinical trials

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NCT ID: NCT05750394 Not yet recruiting - Pregnancy Related Clinical Trials

Cesarean 123 Trial: Randomized Trial Comparing Single, Double and Triple Layer Uterine Closures During Cesarean Delivery

C123T
Start date: July 2023
Phase: N/A
Study type: Interventional

The goal of this clinical trial is to compare post-operative uterine scar thickness in people who have had the uterus closed during cesarean sections by one of three different methods. The main questions it aims to answer are: - Residual myometrial thickness at the scar site assessed by MRI performed 4 months after the procedure - Myometrial niche formation assessed by MRI performed 4 months after the procedure - Scar healing ratio (HR) difference as defined by HR= residual myometrial thickness/total myometrial thickness - Post-operative change in hemoglobin - Time required for hysterotomy closure - The number of extra sutures required to achieve surgeon-acceptable hemostasis Participants undergoing scheduled cesarean sections will be randomized to one of three different uterine closure methods. The methods are: 1. Single layer closure using the following technique: Closure of the myometrium and serosa with one barbed suture using a running unlocked technique. The endometrium should be excluded. 2. Double layer closure using the following technique: Closure of the full thickness of the myometrium with one smooth suture using a running locked technique. The endometrium should be excluded. Followed by imbrication of the second layer with one smooth suture using a running unlocked technique. 3. Triple layer closure of Endometrium, Myometrium and Serosa (EMS) using one of the the following two techniques: Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture using a running unlocked technique followed by closure of the remaining myometrium and serosa with one barbed suture using a running unlocked technique. Or, Closure of the endometrium and 2-4 mm of internal myometrium with one barbed suture on using a running unlocked technique followed by closure of the remaining myometrium with one barbed suture a running unlocked technique followed by closure of the serosa with one barbed suture using a running unlocked technique. Four months after the surgery, participants will have a MRI of the pelvis to assess the scar on the uterus.

NCT ID: NCT05739136 Not yet recruiting - Pregnancy Related Clinical Trials

MYFEMBREE®: A Retrospective Cohort Study Using an Administrative Healthcare Database to Assess Pregnancy Outcomes in Women Treated With Relugolix Combination Therapy

Start date: January 2025
Phase:
Study type: Observational

This is a retrospective cohort study that will be conducted using secondary de-identified electronic healthcare data (EHD) that originally were collected for the purposes of health insurance billing and/or routine patient care from healthcare providers (HCPs). The study is designed to evaluate the association between relugolix combination therapy (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) exposure during pregnancy and subsequent fetal and infant outcomes.

NCT ID: NCT05739123 Recruiting - Pregnancy Related Clinical Trials

Relugolix Pregnancy Registry: An Observational Study of the Safety of Relugolix-Containing Therapy Exposure in Pregnant Women and Their Offspring

Start date: May 8, 2023
Phase:
Study type: Observational [Patient Registry]

The Relugolix Pregnancy Registry is a prospective, observational cohort study designed to evaluate the association between relugolix-containing therapy exposure during pregnancy and subsequent maternal, fetal, and infant outcomes. Data will be collected from enrolled pregnant women and the healthcare providers (HCPs) involved in their care or the care of their infants, if applicable.

NCT ID: NCT05725642 Not yet recruiting - Pregnancy Related Clinical Trials

Prevalence Study and Identification of Factors Prognosis of Obstructive Sleep Apnea Syndrome Sleep in Pregnant Women

SAOSPRONOS
Start date: July 1, 2024
Phase:
Study type: Observational

The exact prevalence of sleep-disordered breathing in pregnant women is not known. The results of a analysis of a small cohort of 105 pregnant women adjusted to body mass index estimate a prevalence of 8.4% in first quarter and 19.7% in the third quarter. In this context, this study proposes to assess the prevalence of sleep-disordered breathing in pregnant women of the Private Hospital of the Loire and to identify the risks associated with these disorders by systematically proposing a polysomnography.

NCT ID: NCT05719467 Recruiting - Pregnancy Related Clinical Trials

SAINT: Safe Induction of Labor Trial

SAINT
Start date: January 3, 2023
Phase: Phase 3
Study type: Interventional

Over the past years, the rates of labor induction have increased steadily, and at present more than one in four births occurs after induced labor in Norway. There is evidence that several groups of women benefit from labor induction, including those with preeclampsia (1), postdate pregnancy, diabetes, a large-for-gestational-age fetus, gestational diabetes, prelabor rupture of membranes at term, preterm prelabor rupture of membranes, twin pregnancy and intrahepatic cholestasis of pregnancy. At the same time, induction of labor is an independent risk factor for adverse obstetric outcomes, including cesarean section, operative vaginal delivery, chorioamnionitis, labor dystocia, prolonged labor, uterine rupture, and neonatal pH < 7.10. A recent Norwegian nationwide clinical practice pilot evaluation demonstrated that the rate of intervention was high, and that as many as 44% of women with labor induction experienced operative delivery. Given that induction of labor is a common procedure (15 000 women per year in Norway) and increases risk of several major obstetric complications, interventions that may reduce operative births and facilitate safe deliveries are highly warranted. Bicarbonate and butylscopolamine bromide have been used in smaller studies in order to shorten labor. The medications seem to be safe with a low frequency of adverse events. The rationale of the present study is therefore to assess the efficacy of oral bicarbonate and intravenous butylscopolamine bromide on facilitating spontaneous (non-operative) delivery in pregnant female participants with induction of labor.

NCT ID: NCT05711875 Completed - Pregnancy Related Clinical Trials

The Effects of Using Virtual Reality Glasses During the Non-Stress Test

Start date: October 15, 2021
Phase: N/A
Study type: Interventional

The aim of this study to determine the effect of virtual reality glasses use on anxiety, stress and fetal well-being during the non-stress test. Personal information form was used as data collection form, Revised Prenatal Distress Questionnaire (NUPDQ-17 Item Version) was used to assess distress, State-Trait Anxiety Inventory (STAI) was used to assessanxiety.

NCT ID: NCT05710003 Not yet recruiting - Pregnancy Related Clinical Trials

Effect of Breathing Exercises and Upper Limb Endurance Exercises in Pregnant Women Presented With Physiological Dyspnea

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

To evaluate the effects of breathing exercises and upper limb endurance exercises in pregnant women presented with physiological dyspnea

NCT ID: NCT05705609 Completed - Pregnancy Related Clinical Trials

The Effect of Mandala Art Therapy on Pregnant Women With Abnormal OGTT

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

The goal of this interventional study is to learn about determine the effect of mandala art therapy on blood glucose level, mood and anxiety in pregnant women with abnormal oral glucose tolerance test (OGTT) value. The main questions it aims to answer are: - Does mandala art therapy affect the mood of pregnant women? - Does mandala art therapy affect the anxiety level of pregnant women? After measuring fasting plasma glucose and drinking oral glucose by the hospital staff in the experimental group in the outpatient clinic, after the 1st and 2nd hour measurements, a total of 2 individual mandala activities (Mandala training certificate was obtained by Dr. Lecturer Esra KARATAŞ OKYAY) will be performed by the researcher.

NCT ID: NCT05703373 Not yet recruiting - Pregnancy Related Clinical Trials

Increasing Access to Multiple Micronutrient Supplementation - A Pilot Intervention at up to 15 Clinics in Botswana

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

The purpose of this study is to pilot a clinic-level supplementation intervention at up to 15 antenatal clinics throughout Botswana. The overall objective of this study is to improve access to and uptake of MMS among pregnant women in Botswana. The investigators will evaluate both implementation outcomes (adoption, penetration, fidelity, and feasibility) and clinical outcomes (adverse birth outcomes, weight gain in pregnancy, and anemia) through linkage with the Tsepamo birth outcomes surveillance study.

NCT ID: NCT05698407 Completed - Pregnancy Related Clinical Trials

Dexmedetomidine-Ropivacine Versus Sufentanil-Ropivacaine for Epidural Labor Analgesia

Start date: March 16, 2023
Phase: Phase 4
Study type: Interventional

Sufentanil-ropivacaine combination is commonly used for epidural labor anesthesia, but is associated with some adverse events. Dexmedetomidine is a high selective alpha2-adrenoceptor agonist. Mounting evidences show that dexmedetomidine-ropivacaine combination can also be used effectively for epidural labor analgesia. This pilot trial is designed to compare the effect of dexmedetomidine-ropivacaine combination versus sufentanil-ropivacaine combination on neonatal outcomes when used for epidural labor analgesia, and to test the feasibility of a future large randomized trial.