Clinical trial NCT02590484: The Cervix as a Natural Tamponade in Postpartum Hemorrhage Caused by Placenta Previa and Placenta Previa Accreta
Official title: The Cervix as a Natural Tamponade in Postpartum Hemorrhage Caused by Placenta Previa and Placenta Previa Accreta: a Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Placenta Previa
Placenta Previa Accreta
Lead sponsor: Minia University
Sponsor class: OTHER
First posted: 2015-10-29
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Primary purpose: TREATMENT

Brief summary: Placenta previa and placenta accrete carry significant maternal and fetal morbidity and mortality. Several techniques have been described in the literature for controlling massive bleeding associated with placenta previa cesarean sections. The aim of this study is to evaluate the efficacy and safety of the use of the cervix as a natural tamponade in controlling postpartum hemorrhage caused by placenta previa and placenta previa accreta.

Detailed description: Background: Placenta previa and placenta accrete carry significant maternal and fetal morbidity and mortality. The maternal mortality in women with placenta accreta may reach as high as 7-10%. Several techniques have been described in the literature for controlling massive bleeding associated with placenta previa cesarean sections, including uterine packing with gauze, balloon tamponades, the B-Lynch suture, insertion of parallel vertical compression sutures, a square suturing technique and embolization or ligation of the uterine and internal iliac arteries, but there is a wide variation in the success rate of these maneuvers. In a case report, Dawlatly et al. (2007) described a simple technique of suturing an inverted lip of the cervix over the bleeding placental bed that was successful in controlling the bleeding, saving the patient's life, and preserving her uterus.

The objective of this trial is to evaluate the safety and efficacy of the use of this Dawlatly stitch as a natural tamponade for controlling postpartum haemorrhage in cases of placenta previa and/ or placenta previa accreta.

Eligibility criteria: Inclusion Criteria:

1. All participating women had one or more previous cesarean deliveries.
2. were diagnosed with placenta previa and/ or placenta previa accreta by ultrasound. When the ultrasound result was not conclusive for placenta accreta, MRI was performed.
3. All participating women desired to preserve their fertility
4. Patients with focal (partial) placenta previa accreta/ placenta previa.

Exclusion Criteria:

1. placenta percreta.
2. diffuse placenta accreta or increta.
3. uncontrollable postpartum hemorrhage.

Primary outcomes:
measure: Successful control of postpartum haemorrhage (PPH)
timeFrame: Intra-operative and up to 24 hours postpartum
measure: Number of cases undergoing hysterectomy to control PPH
timeFrame: Intra-operative and up to 24 hours postpartum
measure: Incidence of complications
timeFrame: short term (intraoperative and up to 6 weeks postpartum)-long term:up to 2 years postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Minia
country: Egypt
facility: Department of Obstetrics and Gynaecology, Minia University Hospital
Study officials:
References:
citation: El Gelany S, Mosbeh MH, Ibrahim EM, Mohammed M, Khalifa EM, Abdelhakium AK, Yousef AM, Hassan H, Goma K, Alghany AA, Mohammed HF, Azmy AM, Ali WA, Abdelraheim AR. Placenta Accreta Spectrum (PAS) disorders: incidence, risk factors and outcomes of different management strategies in a tertiary referral hospital in Minia, Egypt: a prospective study. BMC Pregnancy Childbirth. 2019 Aug 27;19(1):313. doi: 10.1186/s12884-019-2466-5.
citation: El Gelany S, Ibrahim EM, Mohammed M, Abdelraheim AR, Khalifa EM, Abdelhakium AK, Yousef AM, Hassan H, Goma K, Khairy M. Management of bleeding from morbidly adherent placenta during elective repeat caesarean section: retrospective -record -based study. BMC Pregnancy Childbirth. 2019 Mar 29;19(1):106. doi: 10.1186/s12884-019-2244-4.
citation: El Gelany SA, Abdelraheim AR, Mohammed MM, Gad El-Rab MT, Yousef AM, Ibrahim EM, Khalifa EM. The cervix as a natural tamponade in postpartum hemorrhage caused by placenta previa and placenta previa accreta: a prospective study. BMC Pregnancy Childbirth. 2015 Nov 11;15:295. doi: 10.1186/s12884-015-0731-9.