The Cervix as a Natural Tamponade in Postpartum Hemorrhage Caused by Placenta Previa and Placenta Previa Accreta

NCT ID: NCT02590484

Last Updated: 2015-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2018-05-31

Brief Summary

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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

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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.

Conditions

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Placenta Previa Placenta Previa Accreta

Study Design

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Primary Study Purpose

TREATMENT

Interventions

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The cervix as a natural tamponade (cervical inversion)

Suturing an inverted lip(s) of the cervix over the bleeding placental bed to control the bleeding.

Intervention Type PROCEDURE

Other Intervention Names

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Dawlatly stitch, cervical inversion

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Minia University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Rabie Abdelraheim

Dr Ahmed Rabie Abdelraheim, lecturer of Obstetrics And Gynaecology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Obstetrics and Gynaecology, Minia University Hospital

Minya, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed R Abdelraheim, MD, MRCOG

Role: CONTACT

+201096860338

Facility Contacts

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Ahmed Abdelraheim, MD, MRCOG

Role: primary

+201096860338

References

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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.

Reference Type DERIVED
PMID: 31455286 (View on PubMed)

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.

Reference Type DERIVED
PMID: 30922265 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26559634 (View on PubMed)

Other Identifiers

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MUH14367

Identifier Type: -

Identifier Source: org_study_id

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