Placenta PreviaNCT02590484
The Cervix as a Natural Tamponade in Postpartum Hemorrhage Caused by Placenta Previa and Placenta Previa Accreta
A study testing The cervix as a natural tamponade (cervical inversion) in people with Placenta Previa and Placenta Previa Accreta, run by Minia University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Placenta Previa, Placenta Previa Accreta
- What is being tested?
- The cervix as a natural tamponade (cervical inversion)
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteEgypt
- Study dates
- Jun 2012to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Adult
Who may be able to join
- All participating women had one or more previous cesarean deliveries.
- 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.
- All participating women desired to preserve their fertility
- Patients with focal (partial) placenta previa accreta/ placenta previa.
Who cannot join
- placenta percreta.
- diffuse placenta accreta or increta.
- uncontrollable postpartum hemorrhage.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynaecology, Minia University Hospital
Minya
Ahmed Abdelraheim, MD, MRCOG, +201096860338, arabdelraheim@yahoo.com
About this study
Official title: The Cervix as a Natural Tamponade in Postpartum Hemorrhage Caused by Placenta Previa and Placenta Previa Accreta: a Prospective Study
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.
Read the 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.
- Conditions
- Placenta Previa, Placenta Previa Accreta
- Being tested
- The cervix as a natural tamponade (cervical inversion)
- Medical subject headings
- Placenta Previa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The cervix as a natural tamponade (cervical inversion)Procedure or surgery
Also called Dawlatly stitch, cervical inversion
Suturing an inverted lip(s) of the cervix over the bleeding placental bed to control the bleeding.
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful control of postpartum haemorrhage (PPH)
Control of PPH and vaginal bleeding after employing the technique
Measured: Intra-operative and up to 24 hours postpartum
Number of cases undergoing hysterectomy to control PPH
Failure of the technique to stop PPH and need for hysterectomy to stop the bleeding
Measured: Intra-operative and up to 24 hours postpartum
Incidence of complications
Measured: short term (intraoperative and up to 6 weeks postpartum)-long term:up to 2 years postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2015 (estimated)
- Study startJun 2012
- Primary completionMay 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Placenta PreviaStudies of the same condition, open and under way.
- More trials run by Minia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
Sponsor and investigators
- Lead sponsor
- Minia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Rabie Abdelraheim, Minia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02590484
- Sponsor's protocol ID
- MUH14367
- Status last verified
- Oct 2015
- First submitted
- 27 Oct 2015
- Last updated
- 29 Oct 2015
- Results posted
- No
Publications
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.
PubMed 31455286El 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.
PubMed 30922265El 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.
PubMed 26559634
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Cervix as a Natural Tamponade in Postpartum Hemorrhage Caused by Placenta Previa and Placenta Previa Accreta: a Prospective Study
- ClinicalTrials.gov ID
- NCT02590484
- Acronym / sponsor ID
- MUH14367
- Conditions
- Placenta Previa, Placenta Previa Accreta
- Study type
- Interventional
- Recruitment status
- Unknown status
- Lead sponsor
- Minia UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 29 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Age groups
- Adult
Key inclusion criteria (4 listed)
- All participating women had one or more previous cesarean deliveries.
- 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.
- All participating women desired to preserve their fertility
- Patients with focal (partial) placenta previa accreta/ placenta previa.
Key exclusion criteria (3 listed)
- placenta percreta.
- diffuse placenta accreta or increta.
- uncontrollable postpartum hemorrhage.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| The cervix as a natural tamponade (cervical inversion)Also: Dawlatly stitch, cervical inversionSuturing an inverted lip(s) of the cervix over the bleeding placental bed to control the bleeding. | Procedure or surgery | – |
Primary outcome
Successful control of postpartum haemorrhage (PPH)
Time frame: Intra-operative and up to 24 hours postpartum
Control of PPH and vaginal bleeding after employing the technique
Number of cases undergoing hysterectomy to control PPH
Time frame: Intra-operative and up to 24 hours postpartum
Failure of the technique to stop PPH and need for hysterectomy to stop the bleeding
Incidence of complications
Time frame: short term (intraoperative and up to 6 weeks postpartum)-long term:up to 2 years postpartum
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2015.
- Derived from this study: PubMed 31455286El 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.
- Derived from this study: PubMed 30922265El 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.
- Derived from this study: PubMed 26559634El 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The cervix as a natural tamponade (cervical inversion) in people with Placenta Previa and Placenta Previa Accreta, run by Minia University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed R Abdelraheim, MD, MRCOG (+201096860338, arabdelraheim@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful control of postpartum haemorrhage (PPH) (time frame: Intra-operative and up to 24 hours postpartum). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02590484, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2015.