OBJECTIVE: To design and test an in-expensive air-inflated balloon that is easy to sterilize and use for the control of atonic post partum hemorrhage (APPH). PRIMARY OUTCOME MEASURE: Maternal Mortality (MM). SECONDARY OUTCOME MEASURES: Surgical maternal morbidities, amount and doses of drugs, blood transfusion units used for resuscitation, general condition of women on admission and outcome on discharge, the resuscitation time and time for regaining normal uterine tone; hospital stay and ICU admission. TECHNICAL OUTCOMES: Incidence of Balloon rupture, allergic manifestations, and pyrexia. METHODS: Randomized clinical trail / cross over study Two hundred and forty women with diagnosis of atonic PPH complicating vaginal deliveries were randomly assigned to be managed either by ecbolics and uterine massage as recommended by the WHO; or by WHO protocol plus El-Menia air inflated balloon. RESULTS: No maternal mortality in either group. The maternal morbidities in the form of surgical intervention (uterine and ovarian artery ligation, uterine compression suture, internal iliac artery ligation and abdominal hysterectomy) were observed in five women in controls and none in the studied women. Blood transfusion units, ecobolic drugs, resuscitation time, regaining uterine tone time, hospital stay and ICU admission were significantly less in studied women than controls. Out of the 19 failures to arrest APPH in the controls; 14 cases responded to secondary application of El-Menia balloon, and only five cases required surgical intervention. CONCLUSION:El-Menia balloon is an inexpensive, easy to apply, effective in controlling APPH with minimal side effects. It is targeted for use on a large scale in developing countries to reduce the maternal mortality and morbidity caused by APPH.
RCT Entities:
OBJECTIVE: To design and test an in-expensive air-inflated balloon that is easy to sterilize and use for the control of atonic post partum hemorrhage (APPH). PRIMARY OUTCOME MEASURE: Maternal Mortality (MM). SECONDARY OUTCOME MEASURES: Surgical maternal morbidities, amount and doses of drugs, blood transfusion units used for resuscitation, general condition of women on admission and outcome on discharge, the resuscitation time and time for regaining normal uterine tone; hospital stay and ICU admission. TECHNICAL OUTCOMES: Incidence of Balloon rupture, allergic manifestations, and pyrexia. METHODS: Randomized clinical trail / cross over study Two hundred and forty women with diagnosis of atonic PPH complicating vaginal deliveries were randomly assigned to be managed either by ecbolics and uterine massage as recommended by the WHO; or by WHO protocol plus El-Menia air inflated balloon. RESULTS: No maternal mortality in either group. The maternal morbidities in the form of surgical intervention (uterine and ovarian artery ligation, uterine compression suture, internal iliac artery ligation and abdominal hysterectomy) were observed in five women in controls and none in the studied women. Blood transfusion units, ecobolic drugs, resuscitation time, regaining uterine tone time, hospital stay and ICU admission were significantly less in studied women than controls. Out of the 19 failures to arrest APPH in the controls; 14 cases responded to secondary application of El-Menia balloon, and only five cases required surgical intervention. CONCLUSION: El-Menia balloon is an inexpensive, easy to apply, effective in controlling APPH with minimal side effects. It is targeted for use on a large scale in developing countries to reduce the maternal mortality and morbidity caused by APPH.
Authors: V Pingray; M Widmer; A Ciapponi; G J Hofmeyr; C Deneux; M Gülmezoglu; K Bloemenkamp; O T Oladapo; D Comandé; A Bardach; P Vázquez; G Cormick; F Althabe Journal: BJOG Date: 2021-07-19 Impact factor: 7.331
Authors: Joshua P Vogel; Alyce N Wilson; Nick Scott; Mariana Widmer; Fernando Althabe; Olufemi T Oladapo Journal: Int J Gynaecol Obstet Date: 2020-10-30 Impact factor: 3.561