Hemorrhage PostpartumPhase 2NCT03140033
Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery
A Phase 2 study testing Misoprostol Oral Tablet and Ranitidine Oral Tablet in people with Hemorrhage Postpartum, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Trial Read more about this study
- Who is it for?
- Ages 19 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hemorrhage Postpartum
- What is being tested?
- Misoprostol Oral Tablet and Ranitidine Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 158 participants
- Where
- 1 siteEgypt
- Study dates
- Jul 2016to May 2017
- Phase
- Phase 2
- 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 19 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- singleton pregnancies
- women booked for elective C.S
- full term pregnancies
- primi gravida or previous one delivery ( either by spontaneous vaginal delivery or C.S )
Who cannot join
- blood disorders
- multiple pregnancy
- placenta previa
- polyhydramnios
- marked maternal anemia
- contraindications to prostaglandin e.g history of asthma , allergy to misoprostol
- previous 2 or more C.S
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Ain shams maternity hospital
Cairo
Mohamed Fathy, M.B.B.Ch, 00201099984100, Mohamedfathy31085@gmail.com
AMR Helmy, MD.MRCOG, 00201227900014, am_helmy77@hotmail.com
About this study
Official title: Sublingual Misoprostol Versus Placebo to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Study
Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Trial
Read the detailed description
This study aims to evaluate efficacy and safety of subligual misoprostol in reducing blood loss during cesarean section , a randomized double blinded prospective controlled trial conducted at Ain Shams maternity hospital . 158 women who fulfilled the inclusion criteria enrolled in this study .the patients randomized into two groups one of them will receive sublingual misoprostol 400 micrograms ( misotac )and the other will receive placebo( Ranitak ),all patients will subjected to history,physical examination,and investigations.preparation of patients (preload and antibiotics )according to hospital protocol.All C.S will be perfomed using spinal anaesthesia ,pfannenstiel incision of the skin ,open of abdomen in layers ,at cord clamping the patients will receive the medication sublingual and 20IU of oxytocin intravenous infusion simultaneous by the anesthesiologist,then close in anatomical layers.blood loss during C.S will be calculated following placental delivery to the end of surgery,and from the end of the operation to 6h after birth.the need for additional uterotonics agents,blood transfusion and adverse effects of the study drug will be recorded.
- Conditions
- Hemorrhage Postpartum
- Being tested
- Misoprostol Oral Tablet, Ranitidine Oral Tablet
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol Oral TabletDrug
Also called Misotac
at cord clamping the patient will recieve 400 micrograms of misoprostol sublingually
Ranitidine Oral TabletDrug
Also called Ranitak
at cord clamping the patient will recieve ranitidine sublingually
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol oral tablets | Active comparator | 79 women will recieve 400 micrograms of misoprostol ( misotac) sublingually and 20 IU of oxytocin at cord clamping Receives: Drug: Misoprostol Oral Tablet |
| Ranitidine oral tablets | Placebo comparator | 79 women will recieve ranitidine oral tablets sublingually and 20 IU of oxytocin at cord clamping Receives: Drug: Ranitidine Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood loss during cesarean sections
Blood loss will be estimated by the anesthesiologist Using soaked towels and suction set after delivery of placenta
Measured: through study completion, an average of 1 year
Secondary outcomes (7)
Vaginal bleeding
Calculation of the amount of vaginal bleeding according to the number of soaked pads used after cesarea section for the 1st 6 hrs. Each soaked pad equal 50 cc
Measured: through study completion, an average of 1 year
Change in blood pressure and pulse
Change in blood pressure and pulse before and after the cesarean section
Measured: through study completion, an average of 1 year
Blood loss after 24 hr.
The allowable blood loss (ABL) =[ estimated blood volume ( EBV ) x (intial hematocrit (HI ) - final hematocrit (HF) ] / HI ( initial hematocrit)
Measured: through study completion, an average of 1 year
Need for additional uterotonic agent
Need for additional uterotonic agent e.g oxytocin - methyl ergotamine
Measured: through study completion, an average of 1 year
Need for blood transfusion
number of patients receiving blood transfusion
Measured: through study completion, an average of 1 year
Need for surgical measures to stop bleeding
Need for surgical measures to stop bleeding e.g uterine artery ligation , B-lynch sutures or Hysterectomy
Measured: through study completion, an average of 1 year
Side effects of misoprostol
Nausea, Vomiting or Diarrhea
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study startJul 2016
- Primary completionMay 2017 (estimated)
- Study completionMay 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemorrhage PostpartumStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 158 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fathy, Ain Shams Maternity Hospital
- Investigators
- Amr H YEHIA, MD,MRCOG, Study director, Ain Shams University-Maternity Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140033
- Sponsor's protocol ID
- MFathy
- Status last verified
- May 2017
- First submitted
- 24 Apr 2017
- Last updated
- 4 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sublingual Misoprostol Versus Placebo to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03140033
- Acronym / sponsor ID
- MFathy
- Conditions
- Hemorrhage Postpartum
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 158 participants (estimated)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- May 2017 (estimated)
- Study completion
- May 2017 (estimated)
- First posted
- 4 May 2017 (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.
Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Trial
Detailed description
This study aims to evaluate efficacy and safety of subligual misoprostol in reducing blood loss during cesarean section , a randomized double blinded prospective controlled trial conducted at Ain Shams maternity hospital . 158 women who fulfilled the inclusion criteria enrolled in this study .the patients randomized into two groups one of them will receive sublingual misoprostol 400 micrograms ( misotac )and the other will receive placebo( Ranitak ),all patients will subjected to history,physical examination,and investigations.preparation of patients (preload and antibiotics )according to hospital protocol.All C.S will be perfomed using spinal anaesthesia ,pfannenstiel incision of the skin ,open of abdomen in layers ,at cord clamping the patients will receive the medication sublingual and 20IU of oxytocin intravenous infusion simultaneous by the anesthesiologist,then close in anatomical layers.blood loss during C.S will be calculated following placental delivery to the end of surgery,and from the end of the operation to 6h after birth.the need for additional uterotonics agents,blood transfusion and adverse effects of the study drug will be recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol oral tablets | Active comparator | Drug: Misoprostol Oral Tablet79 women will recieve 400 micrograms of misoprostol ( misotac) sublingually and 20 IU of oxytocin at cord clamping |
| Ranitidine oral tablets | Placebo comparator | Drug: Ranitidine Oral Tablet79 women will recieve ranitidine oral tablets sublingually and 20 IU of oxytocin at cord clamping |
Who may qualify
- Ages
- 19 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- singleton pregnancies
- women booked for elective C.S
- full term pregnancies
- primi gravida or previous one delivery ( either by spontaneous vaginal delivery or C.S )
Key exclusion criteria (7 listed)
- blood disorders
- multiple pregnancy
- placenta previa
- polyhydramnios
- marked maternal anemia
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 |
|---|---|---|
| Misoprostol Oral TabletAlso: Misotacat cord clamping the patient will recieve 400 micrograms of misoprostol sublingually | Drug | Misoprostol oral tablets |
| Ranitidine Oral TabletAlso: Ranitakat cord clamping the patient will recieve ranitidine sublingually | Drug | Ranitidine oral tablets |
Primary outcome
Blood loss during cesarean sections
Time frame: through study completion, an average of 1 year
Blood loss will be estimated by the anesthesiologist Using soaked towels and suction set after delivery of placenta
7 secondary outcomes
Vaginal bleeding
Time frame: through study completion, an average of 1 year
Change in blood pressure and pulse
Time frame: through study completion, an average of 1 year
Blood loss after 24 hr.
Time frame: through study completion, an average of 1 year
Need for additional uterotonic agent
Time frame: through study completion, an average of 1 year
Need for blood transfusion
Time frame: through study completion, an average of 1 year
Need for surgical measures to stop bleeding
Time frame: through study completion, an average of 1 year
Side effects of misoprostol
Time frame: through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
- Individual participant dataSharing planned: Yes
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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.
Amr H YEHIA, MD,MRCOG study director
Ain Shams University-Maternity Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Misoprostol Oral Tablet and Ranitidine Oral Tablet in people with Hemorrhage Postpartum, run by Ain Shams Maternity 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 4 inclusion and 7 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 4 May 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Mohamed H Fathy, M.B.B.Ch (00201099984100, Mohamedfathy31085@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood loss during cesarean sections (time frame: through study completion, an average of 1 year). 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 4 May 2017.