Post Operative HemorrhageNCT03444792
Mechanical Dilatation of the Cervix at Elective Caesarean Section to Reduce Post-Operative Blood Loss
A study testing mechanical dilatation of the cervix in people with Post Operative Hemorrhage, run by Cairo University at 1 site in Egypt.
Trial summary
obstetric hemorrhage remains one of the major causes of maternal death in both developed and developing countries. Because of its importance as a leading cause of maternal mortality and morbidity, and because of evidence of substandard care in the majority of fatal cases, obstetric hemorrhage must be considered as a… Read more about this study
- Who is it for?
- Ages 20 to 35 years, women only
- Conditions the study is for
- Post Operative Hemorrhage
- What is being tested?
- mechanical dilatation of the cervix
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 774 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Feb 2018to 20 Jun 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 20 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- pregnant women with a single term fetus >37 weeks of gestational age, with American Society of Anesthesiology (ASA) physical status I or II undergoing Elective Cs (primary or repeated CS).
- Age group 20 - 35 years old
Who cannot join
- Chorioamnionitis.
- Placenta previa.
- Multiple gestations.
- Preeclampsia.
- Macrosomia.
- Hydramnios.
Show all 13Show fewer
- Uterine leiomyomata.
- Anemia.
- Previous cervical surgery.
- Previous post-partum hemorrhage.
- Bleeding tendency.
- Hypertension.
- Diabetes mellitus.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanical Dilatation vs Non-Dilatation of the Cervix at Elective Caesarean Section to Reduce Post-Operative Blood Loss
obstetric hemorrhage remains one of the major causes of maternal death in both developed and developing countries. Because of its importance as a leading cause of maternal mortality and morbidity, and because of evidence of substandard care in the majority of fatal cases, obstetric hemorrhage must be considered as a priority topic for national guideline development.
Some obstetricians believe that the cervix of women at non-labor cesarean section is undilated and might cause obstruction of blood or lochia drainage, leading to postpartum hemorrhage and endometritis from the collection of lochia or debris. Dilatation of the cervix helps with the drainage of blood during postpartum, reducing intrauterine infection or the risk of postpartum hemorrhage. To avoid this problem, some obstetricians routinely dilate the cervix from above during an elective/ non-labor cesarean section using finger, sponge forceps or other instruments
Read the detailed description
Obstetric hemorrhage remains one of the major causes of maternal death in both developed and developing countries.
Because of its importance as a leading cause of maternal mortality and morbidity, and because of evidence of substandard care in the majority of fatal cases, obstetric hemorrhage must be considered as a priority topic for national guideline development. Obstetric hemorrhage encompasses both antepartum and postpartum bleeding.
The direct pregnancy-related maternal mortality rate in the United States is approximately 7-10 women per 100,000 live births. National statistics suggest that approximately 8% of these deaths are caused by Post Partum Hemorrhage (PPH).
In industrialized countries, PPH usually ranks in the top 3 causes of maternal mortality, along with embolism and hypertension. In the developing world, several countries have maternal mortality rates in excess of 1000 women per 100,000 live births, and World Health Organization statistics suggest that 25% of maternal deaths are due to PPH, accounting for more than 100,000 maternal deaths per year . The most recent Practice Bulletin from the American College of Obstetricians and Gynecologists places the estimate at 140,000 maternal deaths per year or 1 woman every 4 minutes. The rate of PPH increased from 1.5% in 1999 to 4.1% in 2009, and the rate of atonic PPH rose from 1% in 1999 to 3.4% in 2009. In the triennium 2006-2008, 261 women in the UK died directly or indirectly related to pregnancy. The overall maternal mortality rate was 11.39 per 100,000 maternities. Direct deaths decreased from 6.24 per 100,000 maternities in 2003-2005 to 4.67 per 100,000 maternities in 2006-2008 (p = 0.02). The number of deaths from postpartum hemorrhage (PPH) has halved to five.
In many countries cesarean section (CS) has become the mode of delivery in over a quarter of all births. It is the most commonly performed operation in obstetrics.
Infectious morbidity is the most frequent complication of cesarean delivery. Of women who have caesareans, 5-24% have clinically significant fevers; and 6-21% are diagnosed with uterine infections (endomyometritis or endometritis), 1- 5% with more extensive pelvic infections including abscesses and 2-9% with a breakdown of the surgical incision, most often caused by wound infection. Strategies to minimize postoperative infectious and other morbidities have included modifications of surgical technique, changing of gloves, methods of placental delivery and altering the uterine position during repair of the uterine incision.
However, none of these studies have evaluated the dilatation of the cervix during elective CS. The practice of routine cervical dilatation at elective cesarean section is performed by some surgeons to facilitate discharge of lochia from a uterus that was not in labor in the immediate postoperative period.
A mechanical dilatation of the cervix at cesarean section is defined as an artificial dilatation of the cervix performed by finger, sponge forceps or other instruments at non-labor cesarean section.An important concern when dilating the cervix in a non-labor uterus is the theoretical risk of ascending infection to the uterus from the vagina, abdominal cavity and abdominal incision. In addition, cervical dilatation may be associated with the creation of a false passage or hemorrhage from cervical injury. However, an undilated cervix may prevent discharge of lochia following elective CS with retention of lochia, a potential culture medium for bacteria, which can cause puerperal genital tract infection. Some published data from developed countries have suggested that there is no difference in outcome between a practice of routine cervical dilatation or non- dilatation at elective cesarean section.
Turnbull's Obstetrics mentions using an extra glove on the left hand to dilate the cervix. The information currently available about the advantages of cervical dilatation at cesarean section is inconclusive. Therefore, evidence to support the effectiveness or safety of cervical dilatation at cesarean section is needed
.
- Conditions
- Post Operative Hemorrhage
- Being tested
- mechanical dilatation of the cervix
- Medical subject headings
- Postoperative Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mechanical dilatation of the cervixProcedure or surgery
the surgeon will perform the cervical dilatation by inserting the double-gloved index finger into the cervical canal of the patients after the extraction of placenta and membranes. The outer glove will be removed after this procedure.
- If failed the surgeon will use artery forceps to dilate cervix
| Study group | Role | What they receive |
|---|---|---|
| Group I (dilation group) | Experimental | the surgeon will perform the cervical dilatation by inserting the double-gloved index finger into the cervical canal of the patients after the extraction of placenta and membranes. The outer glove will be removed after this procedure. - If failed we will use artery forceps to dilate cervix Receives: Procedure: mechanical dilatation of the cervix |
| Group II (non dilatation group) | No intervention | the surgeon will perform cesarian section without attempting cervical dilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vaginal bleeding during the 1st 24 hours postoperative.
The amount of vaginal bleeding will be calculated according to number of soaked pads used after the cesarean section for the 1st 24 hours. Where each soaked pad = 50 cc
Measured: the 1st 24 hours postoperative.
Secondary outcomes (2)
intraoperative blood loss
Blood loss will be estimated by the anesthesia service to guard against potential surgeon bias.
Operative blood loss will be calculated from the amount of blood in the suction bottle after delivery of the placenta and the number of towels used and to which degree they were socked.
Blood from the uterine incision, soaked towels and blood in suction bottle before placental delivery will not be added to the blood measurements.
Soaked towel = 150 cc. Semi-soaked towel = 75 cc. blood measurements. Soaked towel = 150 cc. Semi-soaked towel = 75 cc.
Measured: during the time of the operation
Total blood loss
intraoperative blood loss plus potoperative blood loss
Measured: operation time plus the 1st 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start10 Feb 2018
- Primary completion15 Jun 2018
- Study completion20 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative HemorrhageStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective randomized controlled trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 774 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Samy aly ashour, Cairo University
- Investigators
- mohamed sharkawy, assis.prof., Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03444792
- Sponsor's protocol ID
- cervical dilatation
- Status last verified
- Jul 2018
- First submitted
- 19 Feb 2018
- Last updated
- 6 Jul 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanical Dilatation vs Non-Dilatation of the Cervix at Elective Caesarean Section to Reduce Post-Operative Blood Loss
- ClinicalTrials.gov ID
- NCT03444792
- Acronym / sponsor ID
- cervical dilatation
- Conditions
- Post Operative Hemorrhage
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 774 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Feb 2018 (actual)
- Primary completion
- 15 Jun 2018 (actual)
- Study completion
- 20 Jun 2018 (actual)
- First posted
- 23 Feb 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.
obstetric hemorrhage remains one of the major causes of maternal death in both developed and developing countries. Because of its importance as a leading cause of maternal mortality and morbidity, and because of evidence of substandard care in the majority of fatal cases, obstetric hemorrhage must be considered as a priority topic for national guideline development.
Some obstetricians believe that the cervix of women at non-labor cesarean section is undilated and might cause obstruction of blood or lochia drainage, leading to postpartum hemorrhage and endometritis from the collection of lochia or debris. Dilatation of the cervix helps with the drainage of blood during postpartum, reducing intrauterine infection or the risk of postpartum hemorrhage. To avoid this problem, some obstetricians routinely dilate the cervix from above during an elective/ non-labor cesarean section using finger, sponge forceps or other instruments
Detailed description
Obstetric hemorrhage remains one of the major causes of maternal death in both developed and developing countries.
Because of its importance as a leading cause of maternal mortality and morbidity, and because of evidence of substandard care in the majority of fatal cases, obstetric hemorrhage must be considered as a priority topic for national guideline development. Obstetric hemorrhage encompasses both antepartum and postpartum bleeding.
The direct pregnancy-related maternal mortality rate in the United States is approximately 7-10 women per 100,000 live births. National statistics suggest that approximately 8% of these deaths are caused by Post Partum Hemorrhage (PPH).
In industrialized countries, PPH usually ranks in the top 3 causes of maternal mortality, along with embolism and hypertension. In the developing world, several countries have maternal mortality rates in excess of 1000 women per 100,000 live births, and World Health Organization statistics suggest that 25% of maternal deaths are due to PPH, accounting for more than 100,000 maternal deaths per year . The most recent Practice Bulletin from the American College of Obstetricians and Gynecologists places the estimate at 140,000 maternal deaths per year or 1 woman every 4 minutes. The rate of PPH increased from 1.5% in 1999 to 4.1% in 2009, and the rate of atonic PPH rose from 1% in 1999 to 3.4% in 2009. In the triennium 2006-2008, 261 women in the UK died directly or indirectly related to pregnancy. The overall maternal mortality rate was 11.39 per 100,000 maternities. Direct deaths decreased from 6.24 per 100,000 maternities in 2003-2005 to 4.67 per 100,000 maternities in 2006-2008 (p = 0.02). The number of deaths from postpartum hemorrhage (PPH) has halved to five.
In many countries cesarean section (CS) has become the mode of delivery in over a quarter of all births. It is the most commonly performed operation in obstetrics.
Infectious morbidity is the most frequent complication of cesarean delivery. Of women who have caesareans, 5-24% have clinically significant fevers; and 6-21% are diagnosed with uterine infections (endomyometritis or endometritis), 1- 5% with more extensive pelvic infections including abscesses and 2-9% with a breakdown of the surgical incision, most often caused by wound infection. Strategies to minimize postoperative infectious and other morbidities have included modifications of surgical technique, changing of gloves, methods of placental delivery and altering the uterine position during repair of the uterine incision.
However, none of these studies have evaluated the dilatation of the cervix during elective CS. The practice of routine cervical dilatation at elective cesarean section is performed by some surgeons to facilitate discharge of lochia from a uterus that was not in labor in the immediate postoperative period.
A mechanical dilatation of the cervix at cesarean section is defined as an artificial dilatation of the cervix performed by finger, sponge forceps or other instruments at non-labor cesarean section.An important concern when dilating the cervix in a non-labor uterus is the theoretical risk of ascending infection to the uterus from the vagina, abdominal cavity and abdominal incision. In addition, cervical dilatation may be associated with the creation of a false passage or hemorrhage from cervical injury. However, an undilated cervix may prevent discharge of lochia following elective CS with retention of lochia, a potential culture medium for bacteria, which can cause puerperal genital tract infection. Some published data from developed countries have suggested that there is no difference in outcome between a practice of routine cervical dilatation or non- dilatation at elective cesarean section.
Turnbull's Obstetrics mentions using an extra glove on the left hand to dilate the cervix. The information currently available about the advantages of cervical dilatation at cesarean section is inconclusive. Therefore, evidence to support the effectiveness or safety of cervical dilatation at cesarean section is needed
.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Group I (dilation group) | Experimental | Procedure: mechanical dilatation of the cervixthe surgeon will perform the cervical dilatation by inserting the double-gloved index finger into the cervical canal of the patients after the extraction of placenta and membranes. The outer glove will be removed after this procedure. - If failed we will use artery forceps to dilate cervix |
| Group II (non dilatation group) | No intervention | –the surgeon will perform cesarian section without attempting cervical dilatation |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- pregnant women with a single term fetus >37 weeks of gestational age, with American Society of Anesthesiology (ASA) physical status I or II undergoing Elective Cs (primary or repeated CS).
- Age group 20 - 35 years old
Key exclusion criteria (13 listed)
- Chorioamnionitis.
- Placenta previa.
- Multiple gestations.
- Preeclampsia.
- Macrosomia.
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 |
|---|---|---|
| mechanical dilatation of the cervixthe surgeon will perform the cervical dilatation by inserting the double-gloved index finger into the cervical canal of the patients after the extraction of placenta and membranes. The outer glove will be removed after this procedure. - If failed the surgeon will use artery forceps to dilate cervix | Procedure or surgery | Group I (dilation group) |
Primary outcome
Vaginal bleeding during the 1st 24 hours postoperative.
Time frame: the 1st 24 hours postoperative.
The amount of vaginal bleeding will be calculated according to number of soaked pads used after the cesarean section for the 1st 24 hours. Where each soaked pad = 50 cc
2 secondary outcomes
intraoperative blood loss
Time frame: during the time of the operation
Total blood loss
Time frame: operation time plus the 1st 24 hours after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
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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.
mohamed sharkawy, assis.prof. principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mechanical dilatation of the cervix in people with Post Operative Hemorrhage, 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 2 inclusion and 13 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: finished, as of the sponsor's last update on 6 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vaginal bleeding during the 1st 24 hours postoperative. (time frame: the 1st 24 hours postoperative.). 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 6 Jul 2018.