Placenta AccretaNCT06030492
Efficacy of Hydrogen Peroxide ( H2O2) in Controlling Placental Site Bleeding in Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)
A study testing packing placental site with hydrogen peroxide soaked towels and normal Saline in people with Placenta Accreta, run by Cairo University at 1 site in Egypt.
Trial summary
Placenta accreta spectrum (PAS), encompassing the terms placenta accreta, increta, and percreta; abnormally invasive placenta; morbidly adherent placenta; and invasive placentation, is a leading cause of life-threatening obstetric haemorrage (1) . Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Placenta Accreta
- What is being tested?
- packing placental site with hydrogen peroxide soaked towels and normal Saline
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to 15 Oct 2023
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age from 18-40 years
- BMI < 35 kg/m2
- Pregnant patients with placenta previa .
- Placenta accrete FIGO grade 1 .
- Vitally stable .
- Candidate for conservative management.
- No major intra-operative bleeding.
Who cannot join
- Vitally unstable .
- Massive pre- or intra-operative bleeding.
- Medical disorders ( e.g. : hypertension , cardiac …. )
- Placenta accrete , FIGO grades 2 or 3 .
- Not indicated for conservative management.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Kasr Alainy outpatient infertility clinic
Cairo
bassiony dabian, MD, 1095195513, bassiony.dabian@gmail.com
About this study
Placenta accreta spectrum (PAS), encompassing the terms placenta accreta, increta, and percreta; abnormally invasive placenta; morbidly adherent placenta; and invasive placentation, is a leading cause of life-threatening obstetric haemorrage (1) . Currently, more than 90% of women diagnosed with PAS also have a placenta praevia (2), and the combination of both conditions leads to high maternal morbidity and mortality due to massive haemorrhage at the time of birth . Maternal mortality of placenta praevia with percreta has been reported to be as high as 7% of cases .
Hydrogen peroxide is well-known for its antimicrobial and antiseptic properties. It is used to clean surgical cuts for better localization of bleeding focus in surgery and orthopedics and burn excisions to induce hemostasis . Topical application of hydrogen peroxide was proven to induce hemostasis and reduce operative time in both tonsillectomy and adenoidectomy .
Read the detailed description
- Population of study: A total of 84 pregnant patients with placenta previa / Accreta spectrum.
- Study location: Obstetrics and Gynecology Kasr Al-Ainy Hospital , Faculty of Medicine , Cairo University.
The aim of the study is to evaluate the efficacy of hydrogen peroxide for controlling bleeding from placental bed in caesarian section for placenta previa/ Accreta spectrum (PAS).
- This is a randomized controlled trial including a total number of 84 patients representing study group , randomized in 2 equal groups , using computer generated randomization sheet on (Medcalc ®) .
Group A : hydrogen peroxide group (n=42)
Group B : control group (normal Saline solution) (n=42) .
- Conditions
- Placenta Accreta
- Being tested
- packing placental site with hydrogen peroxide soaked towels, normal Saline
- Medical subject headings
- Placenta Accreta
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
packing placental site with hydrogen peroxide soaked towelsDrug
Skin is incised either midline or Pfannenstiel incision according to clinical situation , bladder dissection will be done , uterus will be incised by transverse lower segment incision , followed by delivery of the baby.
Uterine massage , ecbolics \& a trial for delivery of the placenta will be done Irrigation of the placental bed with 100 ml 3% hydrogen peroxide , followed by packing with a towel highly soaked hydrogen peroxide solution (Pozitif Kimya, İstanbul, Turkey) , freshly prepared by a 50% dilution with a normal saline solution
normal SalineDrug
Skin is incised either midline or Pfannenstiel incision according to clinical situation , bladder dissection will be done , uterus will be incised by transverse lower segment incision , followed by delivery of the baby.
Uterine massage , ecbolics \& a trial for delivery of the placenta will be done.
Packing the placental bed with a towel soaked with normal Saline solution
| Study group | Role | What they receive |
|---|---|---|
| hydrogen peroxide group | Experimental | hydrogen peroxide group Irrigation of the placental bed with 100 ml 3% hydrogen peroxide , followed by packing with a towel highly soaked hydrogen peroxide solution (Pozitif Kimya, İstanbul, Turkey) , freshly prepared by a 50% dilution with a normal saline solution.( Receives: Drug: packing placental site with hydrogen peroxide soaked towels |
| normal Saline solution | Placebo comparator | Packing the placental bed with a towel soaked with normal Saline solution Receives: Drug: normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
control of intra-operative bleeding from placental bed
control of intra-operative bleeding from placental bed
Measured: 3 minutes after application of topical drug , identified as arrest of bleeding or minimal oozing from placental bed with good general condition & no hemoglobin drop
Secondary outcomes (3)
Estimated intraoperative blood loss
Estimated intraoperative blood loss by towel saturarion , amount of blood in suction , and pre\& postoperative hemoglobin and hematocrite
Measured: from begining to end of surgery
Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy
Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy
Measured: 3 minutes after topical application , if bleeding continued
immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)
immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)
Measured: within 1st 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start1 Jan 2023
- Primary completion30 Sep 2023 (estimated)
- Study completion15 Oct 2023 (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 AccretaStudies of the same condition, open and under way.
- More trials run by Cairo 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bassiony Dabian, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06030492
- Sponsor's protocol ID
- MS-467-2023
- Status last verified
- Sep 2023
- First submitted
- 28 Aug 2023
- Last updated
- 11 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sheiner E, Sarid L, Levy A, Seidman DS, Hallak M. Obstetric risk factors and outcome of pregnancies complicated with early postpartum hemorrhage: a population-based study. J Matern Fetal Neonatal Med. 2005 Sep;18(3):149-54. doi: 10.1080/14767050500170088.
PubMed 16272036Jauniaux E, Bhide A, Kennedy A, Woodward P, Hubinont C, Collins S; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Prenatal diagnosis and screening. Int J Gynaecol Obstet. 2018 Mar;140(3):274-280. doi: 10.1002/ijgo.12408. No abstract available.
PubMed 29405319Wasserbauer S, Perez-Meza D, Chao R. Hydrogen peroxide and wound healing: a theoretical and practical review for hair transplant surgeons. Dermatol Surg. 2008 Jun;34(6):745-50. doi: 10.1111/j.1524-4725.2008.34141.x. Epub 2008 Mar 3.
PubMed 18318724
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Hydrogen Peroxide ( H2O2) in Controlling Placental Site Bleeding in Caesarian Delivery for Placenta Previa / Accreta Spectrum ( PAS)
- ClinicalTrials.gov ID
- NCT06030492
- Acronym / sponsor ID
- MS-467-2023
- Conditions
- Placenta Accreta
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Sep 2023 (estimated)
- Study completion
- 15 Oct 2023 (estimated)
- First posted
- 11 Sep 2023 (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.
Placenta accreta spectrum (PAS), encompassing the terms placenta accreta, increta, and percreta; abnormally invasive placenta; morbidly adherent placenta; and invasive placentation, is a leading cause of life-threatening obstetric haemorrage (1) . Currently, more than 90% of women diagnosed with PAS also have a placenta praevia (2), and the combination of both conditions leads to high maternal morbidity and mortality due to massive haemorrhage at the time of birth . Maternal mortality of placenta praevia with percreta has been reported to be as high as 7% of cases .
Hydrogen peroxide is well-known for its antimicrobial and antiseptic properties. It is used to clean surgical cuts for better localization of bleeding focus in surgery and orthopedics and burn excisions to induce hemostasis . Topical application of hydrogen peroxide was proven to induce hemostasis and reduce operative time in both tonsillectomy and adenoidectomy .
Detailed description
- Population of study: A total of 84 pregnant patients with placenta previa / Accreta spectrum.
- Study location: Obstetrics and Gynecology Kasr Al-Ainy Hospital , Faculty of Medicine , Cairo University.
The aim of the study is to evaluate the efficacy of hydrogen peroxide for controlling bleeding from placental bed in caesarian section for placenta previa/ Accreta spectrum (PAS).
- This is a randomized controlled trial including a total number of 84 patients representing study group , randomized in 2 equal groups , using computer generated randomization sheet on (Medcalc ®) .
Group A : hydrogen peroxide group (n=42)
Group B : control group (normal Saline solution) (n=42) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hydrogen peroxide group | Experimental | Drug: packing placental site with hydrogen peroxide soaked towelshydrogen peroxide group Irrigation of the placental bed with 100 ml 3% hydrogen peroxide , followed by packing with a towel highly soaked hydrogen peroxide solution (Pozitif Kimya, İstanbul, Turkey) , freshly prepared by a 50% dilution with a normal saline solution.( |
| normal Saline solution | Placebo comparator | Drug: normal SalinePacking the placental bed with a towel soaked with normal Saline solution |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Age from 18-40 years
- BMI < 35 kg/m2
- Pregnant patients with placenta previa .
- Placenta accrete FIGO grade 1 .
- Vitally stable .
Key exclusion criteria (5 listed)
- Vitally unstable .
- Massive pre- or intra-operative bleeding.
- Medical disorders ( e.g. : hypertension , cardiac …. )
- Placenta accrete , FIGO grades 2 or 3 .
- Not indicated for conservative management.
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 |
|---|---|---|
| packing placental site with hydrogen peroxide soaked towelsSkin is incised either midline or Pfannenstiel incision according to clinical situation , bladder dissection will be done , uterus will be incised by transverse lower segment incision , followed by delivery of the baby. Uterine massage , ecbolics \& a trial for delivery of the placenta will be done Irrigation of the placental bed with 100 ml 3% hydrogen peroxide , followed by packing with a towel highly soaked hydrogen peroxide solution (Pozitif Kimya, İstanbul, Turkey) , freshly prepared by a 50% dilution with a normal saline solution | Drug | hydrogen peroxide group |
| normal SalineSkin is incised either midline or Pfannenstiel incision according to clinical situation , bladder dissection will be done , uterus will be incised by transverse lower segment incision , followed by delivery of the baby. Uterine massage , ecbolics \& a trial for delivery of the placenta will be done. Packing the placental bed with a towel soaked with normal Saline solution | Drug | normal Saline solution |
Primary outcome
control of intra-operative bleeding from placental bed
Time frame: 3 minutes after application of topical drug , identified as arrest of bleeding or minimal oozing from placental bed with good general condition & no hemoglobin drop
control of intra-operative bleeding from placental bed
3 secondary outcomes
Estimated intraoperative blood loss
Time frame: from begining to end of surgery
Need for hemostatic sutures , uterine artery ligation , internal iliac artery ligation , hysterectomy
Time frame: 3 minutes after topical application , if bleeding continued
immediate maternal complications ( postpartum haemorrage , DIC , hysterectomy , maternal mortality , ICU admission , …)
Time frame: within 1st 24 hours postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2023.
- Background: PubMed 16272036Sheiner E, Sarid L, Levy A, Seidman DS, Hallak M. Obstetric risk factors and outcome of pregnancies complicated with early postpartum hemorrhage: a population-based study. J Matern Fetal Neonatal Med. 2005 Sep;18(3):149-54. doi: 10.1080/14767050500170088.
- Background: PubMed 29405319Jauniaux E, Bhide A, Kennedy A, Woodward P, Hubinont C, Collins S; FIGO Placenta Accreta Diagnosis and Management Expert Consensus Panel. FIGO consensus guidelines on placenta accreta spectrum disorders: Prenatal diagnosis and screening. Int J Gynaecol Obstet. 2018 Mar;140(3):274-280. doi: 10.1002/ijgo.12408. No abstract available.
- Background: PubMed 18318724Wasserbauer S, Perez-Meza D, Chao R. Hydrogen peroxide and wound healing: a theoretical and practical review for hair transplant surgeons. Dermatol Surg. 2008 Jun;34(6):745-50. doi: 10.1111/j.1524-4725.2008.34141.x. Epub 2008 Mar 3.
- Individual participant dataSharing planned: Undecided
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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 packing placental site with hydrogen peroxide soaked towels and normal Saline in people with Placenta Accreta, run by Cairo 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 7 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 11 Sep 2023. 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. Some participants in this study may receive a placebo. 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 bassiony dabian, MD (1095195513, bassiony.dabian@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
control of intra-operative bleeding from placental bed (time frame: 3 minutes after application of topical drug , identified as arrest of bleeding or minimal oozing from placental bed with good general condition & no hemoglobin drop). 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 NCT06030492, 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 11 Sep 2023.