Cesarean Section ComplicationsNCT03701386
Comparison of N&H Sandwich Technique and Cesarean Hysterectomy in Management of Placenta Accreta Spectrum
A study testing cesarean hysterectomy and N&H sandwich technique in people with Cesarean Section Complications, run by Aswan University Hospital at 1 site in Egypt.
Trial summary
The placenta accreta spectrum (PAS)is one of the most common reasons for cesarean hysterectomy Which associated with high rates of severe maternal morbidity (40%-50%), with reported mortality rates up to 7%. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women only
- Conditions the study is for
- Cesarean Section Complications
- What is being tested?
- cesarean hysterectomy and N&H sandwich technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2018to 1 Jan 2022
- 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 20 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- all pregnant women with a full-term pregnancy with placenta accreta spectrum
Who cannot join
- Patients with a cardiac, hepatic, renal or thromboembolic disease.
- patients with pelvic endometriosis and adnexal mass.
- those presented with severe antepartum hemorrhage will be excluded
- known coagulopathy
- twin pregnancy
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Aswan University
Aswān, 81528
hany f sallam, md, 01092440504 ext. 002, nahla.elsayed@aswu.ed.eg
About this study
Official title: Comparison of N&H Sandwich Technique and Cesarean Hysterectomy in Management of Placenta Accreta Spectrum: A Randomized Controlled Trial
The placenta accreta spectrum (PAS)is one of the most common reasons for cesarean hysterectomy Which associated with high rates of severe maternal morbidity (40%-50%), with reported mortality rates up to 7%. And, a cesarean hysterectomy might not be considered first-line treatment for women who have a strong desire for future fertility.
Conservative management of PAS defines all procedures that aim to avoid peripartum hysterectomy and its related morbidity and consequences.
The main types of conservative management which have been described in the literature: the extirpative technique (manual removal of the placenta); leaving the placenta in situ or the expectant approach; one-step conservative surgery and the Triple-P procedure. These methods have been used alone or in combination and in many cases with additional procedures such as those proposed by interventional radiology.
Read the detailed description
patients were allocated to one of two groups. Group (I): patients will be received N\&H technique Group (II): patients will be received cesarean hysterectomy. In the N\&H group, after acceptable control of bleeding from the placental bed, the internal os of the cervix was identified a double uterine compression suture at the lower uterine segment with inflated Foley's catheter balloon tamponade was performed as follow: (i) 100-cm Vicryl no. 1 was thrown to form two nearly equal parts (each 50 cm) on a blunt semicircular 70-mm needle, the curve of the needle was straightened.
(ii) The needle transfixed the right side of the uterine wall from anterior to posterior, about5 cm below the hysterotomy incises posterior, then the needle transfixed the left side of the uterine wall from posterior to anterior, about 2 cm below the hysterotomy incision.
(iii) another transverse compression suture undertook above the first one by 3 cm and below the hysterotomy incision by 2 cm.
(iv) At the end of the suture application and before tying the knots, the internal os of the cervix was identified and a double-way 20 Fr Foley's catheter with a 30-50-ml balloon (Medical Industries, 10th of Ramadan City, Egypt) was inserted through the cervix to be handled by an assistant through the vagina and fixed to the patient's lower limb after inflation of the catheter balloon by 80 ml warm saline and pulling it against the lower uterine segment between the two transverse sutures . Only one catheter was used for tamponade.
(v) Lastly ties the sutures.
- Conditions
- Cesarean Section Complications
- Being tested
- cesarean hysterectomy, N&H sandwich technique
- Keywords
- cesarean section, placenta accreta spectrum, N&H sandwich technique
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cesarean hysterectomyProcedure or surgery
Elective cesarean hysterectomy will be planned at 37-38 weeks of gestation. An adequate amount of blood products was prepared to be available for transfusion. Delivery will be performed by the same multidisciplinary team, including two expert obstetricians, an assistant, an expert anesthesiologist, and a pediatrician.
N&H sandwich techniqueProcedure or surgery
In the N\&H group, after acceptable control of bleeding from the placental bed, the internal os of the cervix was identified a double uterine compression suture at the lower uterine segment with inflated Foley's catheter balloon tamponade will be performed
| Study group | Role | What they receive |
|---|---|---|
| cesarean hysterectomy | Active comparator | Elective Cesarean hysterectomy will be planned at 37-38 weeks of gestation. An adequate amount of blood products was prepared to be available for transfusion. The operation will be performed by the same multidisciplinary team, including two expert obstetricians, an assistant, an expert anesthesiologist, and a pediatrician. Receives: Procedure: cesarean hysterectomy |
| N&H sandwich technique | Experimental | In the N\&H group, after acceptable control of bleeding from the placental bed, the internal os of the cervix was identified a double uterine compression suture at the lower uterine segment with inflated Foley's catheter balloon tamponade was performed Receives: Procedure: N&H sandwich technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraoperative blood loss
measures the intraoperative blood loss by direct and gravimetric methods
Measured: during the operation
Secondary outcomes (4)
postoperative blood loss
measures the intraoperative blood loss by direct and gravimetric methods
Measured: 24 hours postoperative
need of blood transfusion
number of unites of blood transfusion
Measured: ist 24 hours postoperative
need of other surgical maneuvers
for example internal iliac artery ligation
Measured: during the operation
operative time
time from skin incision to skin closure
Measured: during the operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2018
- Study start1 Nov 2018
- Primary completion30 Oct 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean Section ComplicationsStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The eligible participant will be allocated to groups, group one will receive cesarean hysterectomy and group 2 will be received N\&H sandwich technique
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aswan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, hany farouk, Aswan University Hospital
- Investigators
- hany f sallam, md, Principal investigator, Aswan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03701386
- Sponsor's protocol ID
- aswu /296/9/18
- Status last verified
- Dec 2018
- First submitted
- 5 Oct 2018
- Last updated
- 13 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of N&H Sandwich Technique and Cesarean Hysterectomy in Management of Placenta Accreta Spectrum: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03701386
- Acronym / sponsor ID
- aswu /296/9/18
- Conditions
- Cesarean Section Complications
- Keywords
- cesarean section, placenta accreta spectrum, N&H sandwich technique
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aswan University HospitalUniversity, hospital or other
- Study start
- 1 Nov 2018 (actual)
- Primary completion
- 30 Oct 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 10 Oct 2018 (actual)
- 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.
The placenta accreta spectrum (PAS)is one of the most common reasons for cesarean hysterectomy Which associated with high rates of severe maternal morbidity (40%-50%), with reported mortality rates up to 7%. And, a cesarean hysterectomy might not be considered first-line treatment for women who have a strong desire for future fertility.
Conservative management of PAS defines all procedures that aim to avoid peripartum hysterectomy and its related morbidity and consequences.
The main types of conservative management which have been described in the literature: the extirpative technique (manual removal of the placenta); leaving the placenta in situ or the expectant approach; one-step conservative surgery and the Triple-P procedure. These methods have been used alone or in combination and in many cases with additional procedures such as those proposed by interventional radiology.
Detailed description
patients were allocated to one of two groups. Group (I): patients will be received N\&H technique Group (II): patients will be received cesarean hysterectomy. In the N\&H group, after acceptable control of bleeding from the placental bed, the internal os of the cervix was identified a double uterine compression suture at the lower uterine segment with inflated Foley's catheter balloon tamponade was performed as follow: (i) 100-cm Vicryl no. 1 was thrown to form two nearly equal parts (each 50 cm) on a blunt semicircular 70-mm needle, the curve of the needle was straightened.
(ii) The needle transfixed the right side of the uterine wall from anterior to posterior, about5 cm below the hysterotomy incises posterior, then the needle transfixed the left side of the uterine wall from posterior to anterior, about 2 cm below the hysterotomy incision.
(iii) another transverse compression suture undertook above the first one by 3 cm and below the hysterotomy incision by 2 cm.
(iv) At the end of the suture application and before tying the knots, the internal os of the cervix was identified and a double-way 20 Fr Foley's catheter with a 30-50-ml balloon (Medical Industries, 10th of Ramadan City, Egypt) was inserted through the cervix to be handled by an assistant through the vagina and fixed to the patient's lower limb after inflation of the catheter balloon by 80 ml warm saline and pulling it against the lower uterine segment between the two transverse sutures . Only one catheter was used for tamponade.
(v) Lastly ties the sutures.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The eligible participant will be allocated to groups, group one will receive cesarean hysterectomy and group 2 will be received N\&H sandwich technique
| Arm | Type | Receives |
|---|---|---|
| cesarean hysterectomy | Active comparator | Procedure: cesarean hysterectomyElective Cesarean hysterectomy will be planned at 37-38 weeks of gestation. An adequate amount of blood products was prepared to be available for transfusion. The operation will be performed by the same multidisciplinary team, including two expert obstetricians, an assistant, an expert anesthesiologist, and a pediatrician. |
| N&H sandwich technique | Experimental | Procedure: N&H sandwich techniqueIn the N\&H group, after acceptable control of bleeding from the placental bed, the internal os of the cervix was identified a double uterine compression suture at the lower uterine segment with inflated Foley's catheter balloon tamponade was performed |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all pregnant women with a full-term pregnancy with placenta accreta spectrum
Key exclusion criteria (5 listed)
- Patients with a cardiac, hepatic, renal or thromboembolic disease.
- patients with pelvic endometriosis and adnexal mass.
- those presented with severe antepartum hemorrhage will be excluded
- known coagulopathy
- twin pregnancy
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 |
|---|---|---|
| cesarean hysterectomyElective cesarean hysterectomy will be planned at 37-38 weeks of gestation. An adequate amount of blood products was prepared to be available for transfusion. Delivery will be performed by the same multidisciplinary team, including two expert obstetricians, an assistant, an expert anesthesiologist, and a pediatrician. | Procedure or surgery | cesarean hysterectomy |
| N&H sandwich techniqueIn the N\&H group, after acceptable control of bleeding from the placental bed, the internal os of the cervix was identified a double uterine compression suture at the lower uterine segment with inflated Foley's catheter balloon tamponade will be performed | Procedure or surgery | N&H sandwich technique |
Primary outcome
intraoperative blood loss
Time frame: during the operation
measures the intraoperative blood loss by direct and gravimetric methods
4 secondary outcomes
postoperative blood loss
Time frame: 24 hours postoperative
need of blood transfusion
Time frame: ist 24 hours postoperative
need of other surgical maneuvers
Time frame: during the operation
operative time
Time frame: during the operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2018.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section Complications
Recruiting
Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
Not yet recruiting
Empowered Relief for Severe Pain After Cesarean Delivery During the Inpatient Period
Severe Pain, Cesarean Section Complications
Recruiting
Platelet Rich Plasma for Uterine Scar
Cesarean Section Complications, Uterine Bleeding
Enrolling by invitation
Using Empowered Relief and Education To Help Postpartum Women Recover After Cesarean Delivery
Cesarean Section Complications, Postpartum Care
Recruiting
Personalized Perioperative Analgesia Platform (PPAP) for Cesarean Section
Cesarean Section Complications, Opioid Use
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.
hany f sallam, md principal investigator
Aswan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cesarean hysterectomy and N&H sandwich technique in people with Cesarean Section Complications, run by Aswan University Hospital 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 1 inclusion and 5 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 13 Dec 2018. 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 hany f sallam, md (01022336052 ext. 002, hany.farouk@aswu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
intraoperative blood loss (time frame: during the operation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Dec 2018.