Safety and efficacy of the new CryoPop® cryotherapy device for cervical dysplasia in low- and middle-income countries: study protocol for a multicenter open-label non-inferiority clinical trial with historical controls.

BACKGROUND: Cervical cancer is the fourth most common cancer in the world, affecting mainly women residing in low- and middle-income countries. Progression from a pre-invasive phase to that of an invasive phase generally takes years and provides a window of opportunity to screen for and treat precancerous lesions. METHODS: This study is being conducted at four sites in north Karnataka, India. Community sensitization activities have been organized in the study areas to create awareness among stakeholders, including elected representatives, physicians, health care workers, and potential participants. Organized community based as well as hospital-based screening is being conducted using visual inspection with acetic acid (VIA). Screen positive women are referred to respective study hospitals for colposcopy and directed biopsy. Participants with confirmed high-grade cervical dysplasia (high-grade squamous intraepithelial lesions or HSIL) who fit all other eligibility criteria will be recruited to the study and will receive cryotherapy using CryoPop®, an innovative new cryotherapy device. DISCUSSION: There is a need to develop an inexpensive, simple, and effective cryotherapy device for use by frontline health care providers at locations where screening and timely treatment can be given, accelerating access to cervical cancer prevention services and minimizing loss to follow-up of women with precancerous lesions who need treatment. TRIAL REGISTRATION: Clinical Trial Registry - India CTRI/2019/01/017289 ClinicalTrials.Gov number NCT04154644 . Registered on November 6, 2019.

Emergency peripartum hysterectomy: a 13-year review at a tertiary center in kuwait.

OBJECTIVE: To determine the incidence, indications, risk factors, and complications of emergency peripartum hysterectomy (EPH) and to evaluate total versus subtotal hysterectomy for EPH. MATERIALS AND METHODS: This is a retrospective case series involving thorough examination of the files of all women who had EPH between January 2000 and December 2012 in the department of Obstetrics and Gynecology, Al-Jahra hospital, Kuwait after taking approval from the ethics committee. Incidence, indications, risk factors, type of hysterectomy, and complications of EPH were obtained from patient files. RESULTS: There were 63,337 deliveries of which 70.3 % were vaginal deliveries, and 29.6 % were by cesarean section (CS). Sixty-eight women underwent EPH representing an overall incidence of 1 case per 1,000 deliveries. The indications for EPH included abnormal placentation (77.4 %), uterine atony (14.5 %), and uterine rupture (8.1 %). There was one maternal death. Maternal morbidity occurred in 25 (40.3 %) women. The most common complications were mild to severe coagulopathy (19.35 %) and injury to the urinary tract (17.74 %). Injury to the ureter was avoided by placing ureteric stents preoperatively. Our population was significant in having higher rate of CS deliveries (91.9 %), women with prior CS (83.87 %), and high parity (mean 5.8). CONCLUSION: Abnormal placentation was the most common indication to perform EPH. The relative risk of EPH was 27 for CS deliveries as compared to vaginal deliveries. There was no significant difference between subtotal versus total hysterectomy with respect to age, parity, previous CS, operative time, blood transfusion, and intra and post operative complications.