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Uterine Fibroid clinical trials

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NCT ID: NCT03927651 Completed - Endometriosis Clinical Trials

ICG to Assess Ovarian Perfusion

Start date: June 1, 2019
Phase: Early Phase 1
Study type: Interventional

To assess the feasibility of using intravenous ICG to characterize the vascular perfusion of ovaries during gynecologic surgery

NCT ID: NCT03792009 Recruiting - Adenomyosis Clinical Trials

Paracervical Block in Laparoscopic Hysterectomy

PALAPA
Start date: February 21, 2019
Phase: N/A
Study type: Interventional

It remains controversial whether paracervical block should be performed as a powerful strategy for pain relief in total laparoscopic hysterectomy (TLH), because convincing conclusions are difficult to draw because of the heterogeneous and contradictory nature of the literature. Therefore, the aim of this study was to evaluate the efficacy of paracervical blocks using with 0.5% bupivacaine prior to TLHs for benign gynecologic conditions on postoperative pain relief.

NCT ID: NCT03744507 Completed - Endometriosis Clinical Trials

Bone Mineral Density in Women With Uterine Fibroids or Endometriosis

Start date: August 3, 2018
Phase:
Study type: Observational

The purpose of this study is to characterize the longitudinal bone mineral density (BMD) in premenopausal women with uterine fibroids or endometriosis.

NCT ID: NCT03509168 Recruiting - Uterine Fibroid Clinical Trials

The Efficacy and Safety of Preoperative Misoprostol in Blood-loss Reduction During Myomectomy.

MM
Start date: January 10, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Open myomectomy remains the principal treatment for symptomatic fibroids in sub-Saharan countries irrespective of fertility desires. This however has got to be balanced against potential risks such as profuse hemorrhage; blood loss at open myomectomy remains dreary with the use of various pharmacologic agents yielding inconclusive results. This trial is aimed at exploring the benefit of preoperative use of a readily available uterotonic, Misoprostol in reduction of intraoperative blood loss during open myomectomy with the Null hypothesis stating: there is no difference in mean blood loss during open myomectomy whether one preoperatively inserts a single dose of 400mcg vaginal misoprostol or not. Alternate hypothesis: single dose 400mcg vaginal Misoprostol given 60 minutes preoperatively during open myomectomy reduces intra-operative blood loss by at least 20% as measured by surgical mops and suction. Participants from two referral hospitals in Uganda with symptomatic fibroids and scheduled for open myomectomy will be recruited. 48 women that meet the inclusion criteria and have none of the exclusion criteria and provide signed informed consent will be enrolled. The screening will be done on the gynecological wards and patients will be randomized to either the control or interventional arm by means of sealed, sequentially numbered opaque envelopes containing computer-generated random numbers. Blinding will affect theatre team and patients. Primary (blood loss as estimated by surgical mops and suction) and secondary endpoints (e.g. postoperative drop in Hb) will be calculated. Data analysis: Data will be analyzed on an intention-to-treat basis. Analysis will be done using STATA software 14.0. This will include descriptive statistics for measures of central tendency and dispersion. Student t-test and Mann Whitney U test will be used for mean blood loss. Stratification for age, parity, complaints, total fibroid mass and usage of other intraoperative blood-loss techniques will be analyzed. categorical data to be analyzed by coefficients. Results of this study are meant to better inform clinicians about the use of misoprostol for this role and possibly include it in the management protocols for open myomectomy in Sub-Saharan countries where burden of blood products is strained.

NCT ID: NCT03450421 Not yet recruiting - Uterine Fibroid Clinical Trials

Safety and Efficacy of Actamax™Adhesion Barrier in Women Undergoing Laparoscopic Abdominopelvic Surgery/Myomectomy

Start date: June 2018
Phase: N/A
Study type: Interventional

Women undergoing laparoscopic abdominopelvic surgery with a planned, second look laparoscopy within 8-12 (+4) weeks will be enrolled. All subjects must undergo myomectomy with/without treatment of co-existing pathology e.g. (+/-) adhesions and/or (+/-) endometriosis, and/or (+/-) adenomyosis, and/or (+/-) ovarian cyst(s). The value of the second look laparoscopy (SLL) must be confirmed by the investigator to be of clinical benefit to the subject. The subject must be desirous of future fertility and willing to undergo the SLL to assess whether pathology (e.g. adnexal adhesions or endometriosis) exists which could be treated with a goal of improving their likelihood of conceiving and progressing to full term.

NCT ID: NCT03444987 Completed - Uterine Fibroid Clinical Trials

The Role of Fibroblast Activation in Uterine Fibroid

Start date: March 1, 2018
Phase:
Study type: Observational

Uterine fibroids (UFs), also called uterine leiomyomas or myomas, are steroid hormone-responsive, benign tumors of the smooth muscle compartment (myometrium) of the uterus. They are the most common neoplasm affecting women in their reproductive age. It is estimated that up to 77% of women develop UF in their life. UFs are one of the leading causes of hospitalisations for gynaecological disorders and are the most frequent reason for hysterectomy. According to relevant literature, 40%-60% of all the hysterectomies performed are due to the presence of UFs.

NCT ID: NCT03427671 Completed - Leiomyoma Clinical Trials

OCL 500 Treatment of Women With Symptomatic Uterine Fibroids

Start date: January 17, 2018
Phase: N/A
Study type: Interventional

This is a prospective, open-label, single-arm, safety and effectiveness study of Occlusin 500 microspheres in women with symptomatic uterine fibroids.

NCT ID: NCT03412890 Completed - Uterine Fibroid Clinical Trials

LIBERTY EXTENSION: Efficacy and Safety Extension Study of Relugolix in Women With Heavy Menstrual Bleeding Associated With Uterine Fibroids

Start date: October 19, 2017
Phase: Phase 3
Study type: Interventional

The purpose of this study was to determine the long-term efficacy and safety of relugolix 40 milligrams (mg) once daily co-administered with estradiol (E2) and norethindrone acetate (NETA) for 28 weeks on heavy menstrual bleeding associated with uterine fibroids in participants who previously completed a 24-week treatment period in one of the pivotal studies (MVT-601-3001 or MVT-601-3002).

NCT ID: NCT03270605 Completed - Cesarean Section Clinical Trials

Myomectomy During CS: A Retrospective Cohort Study

Start date: January 1, 2015
Phase:
Study type: Observational

To evaluate the value of myomectomy during delivery by cesarean section (CS) in pregnant women with uterine fibroids.

NCT ID: NCT03211481 Completed - Uterine Fibroid Clinical Trials

Design of an Intra-operative Blood Conservation Pathway at Open Myomectomy

Start date: June 13, 2017
Phase:
Study type: Observational

Uterine fibroids are benign uterine masses that can be removed through a surgical procedure called a myomectomy. Myomectomy is often associated with a significant amount of blood loss for the patient. The large volume of blood lost can increase post-operative complications and lead patients to require blood replacement (blood transfusion). To reduce the amount of blood lost during the surgical procedure and the need for blood transfusions, interventions such as medications and surgical techniques have been used. While evidence in the literature exists for these techniques, there is no standardized approach to this problem in clinical practice. The objective of this study is to create a novel intra-operative blood conservation pathway, using a modified Delphi expert consensus approach, to decrease the amount of blood lost during myomectomy. The current study is expected to benefit patients undergoing myomectomy through an improved surgical experience, reduction in blood transfusion rates, and reduction in associated complications.