Prevention of Post Partum Hemorrhage After Labor InductionNCT02983591
Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin
A study testing Misoprostol after delivery, Oxytocin after delivery and Oxytocin before delivery in people with Prevention of Post Partum Hemorrhage After Labor Induction, run by Makassed General Hospital at 1 site in Lebanon.
Trial summary
The use of Oxytocin for labor induction may cause receptor exhaustion and thus making its use in the third stage of labor ineffective in reducing post partum blood loss as compared to other uterotonics.So, we studied the effect of other uterotonic which is misoprostol in reducing post partum hemorrhage. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Prevention of Post Partum Hemorrhage After Labor Induction
- What is being tested?
- Misoprostol after delivery, Oxytocin after delivery and Oxytocin before delivery
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteLebanon
- Study dates
- Nov 2016to 30 Dec 2017
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- women with single viable pregnancy,
- cephalic presentation,
- at full term
- whom labor was induced by Oxytocin were eligible
Who cannot join
- delivery by cesarean section
- received other prophylactic uterotonics
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin: a Prospective Randomized Controlled Trial
The use of Oxytocin for labor induction may cause receptor exhaustion and thus making its use in the third stage of labor ineffective in reducing post partum blood loss as compared to other uterotonics.So, we studied the effect of other uterotonic which is misoprostol in reducing post partum hemorrhage.
Read the detailed description
Our study will be carried out at Makassed General Hospital, a tertiary-level maternity unit performing about 1000 deliveries annually. After approval by the hospital Ethics and Research Committee, women with single viable pregnancy, in cephalic presentation, at full term and whom labor was induced by Oxytocin will be eligible for inclusion.
After informed consents is obtained, the parturients will be assigned randomly according to a computer generated sequence in block lists of 25each time to receive either 1000mcg of Misoprostol rectally or 20 units of Oxytocin intravenously to run at a rate of 150ml/hr. The medications will be given just after cord clamping and before delivery of the placenta. Active management of the third stage of labor will be carried out simultaneously with early cord clamping, gentle downward traction of the placenta to hasten its delivery, and uterine massage in addition to the uterotonic according to assignment of the patient. Assessment of the uterine condition will be done by the obstetrician or his assistant, together with visually estimating the amount of blood loss. Once uterine atony or estimated blood loss (EBL) of more than 500 ml is noticed, another uterotonics will be administered according to the condition and at the discretion of the obstetrician.
Failure to achieve adequate uterine contraction and to control post partum hemorrhage (PPH) by the routine uterine massage will urge the use of either different uterotonics or surgical intervention if necessary. Blood transfusion will be ordered for the cases whose visual estimation of blood loss is more than 1000ml or when the patient was hemodynamically unstable. In order to compare the effect of each medication alone on the amount of blood loss, we will then exclude those patients who received blood transfusion or additional uterotonics. A base line hemoglobin and hematocrit levels will be withdrawn on admission and another reading 12 hours postpartum.
- Being tested
- Misoprostol after delivery, Oxytocin after delivery, Oxytocin before delivery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Misoprostol after deliveryDrug
Patients will receive 1000 mcg Misoprostol per rectum
Oxytocin after deliveryDrug
Patients will receive 20 units oxytocin intravenously in one liter of Lactated Ringer solution at a rate of 150ml/h
Oxytocin before deliveryDrug
All patients will receive oxytocin 0.5-1 milliUnit/min IV, titrated to 1-2 milliUnit/min every 15-60 min before delivery to induce labor
| Study group | Role | What they receive |
|---|---|---|
| Misoprostol | Experimental | Rectal misoprostol Receives: Drug: Misoprostol after delivery; Drug: Oxytocin before delivery |
| Oxytocin | Experimental | intravenous oxytocin Receives: Drug: Oxytocin after delivery; Drug: Oxytocin before delivery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemoglobin level
10% or more drop in hemoglobin
Measured: 12 to 24 hours post partum
Secondary outcomes (4)
mean hemoglobin drop
difference between pre and post partum hemoglobin levels
Measured: 12 to 24 hours post partum
mean estimated blood loss
visual estimation of blood loss
Measured: during the first hour post partum
drop in hemoglobin
2g/dl drop in hemoglobin
Measured: 12 to 24 hours post partum
side effect of medication
fever > 38°C, diarrhea, and shivering
Measured: upto 48 hours after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startNov 2016
- Primary completion30 Dec 2017
- Study completion30 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prevention of Post Partum Hemorrhage After Labor InductionStudies 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
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Makassed General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Manal Hubeish, Makassed General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983591
- Sponsor's protocol ID
- 16082016
- Status last verified
- Jan 2018
- First submitted
- 30 Nov 2016
- Last updated
- 16 Jan 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin: a Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02983591
- Acronym / sponsor ID
- 16082016
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Makassed General HospitalUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- 30 Dec 2017 (actual)
- Study completion
- 30 Dec 2017 (actual)
- First posted
- 6 Dec 2016 (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.
The use of Oxytocin for labor induction may cause receptor exhaustion and thus making its use in the third stage of labor ineffective in reducing post partum blood loss as compared to other uterotonics.So, we studied the effect of other uterotonic which is misoprostol in reducing post partum hemorrhage.
Detailed description
Our study will be carried out at Makassed General Hospital, a tertiary-level maternity unit performing about 1000 deliveries annually. After approval by the hospital Ethics and Research Committee, women with single viable pregnancy, in cephalic presentation, at full term and whom labor was induced by Oxytocin will be eligible for inclusion.
After informed consents is obtained, the parturients will be assigned randomly according to a computer generated sequence in block lists of 25each time to receive either 1000mcg of Misoprostol rectally or 20 units of Oxytocin intravenously to run at a rate of 150ml/hr. The medications will be given just after cord clamping and before delivery of the placenta. Active management of the third stage of labor will be carried out simultaneously with early cord clamping, gentle downward traction of the placenta to hasten its delivery, and uterine massage in addition to the uterotonic according to assignment of the patient. Assessment of the uterine condition will be done by the obstetrician or his assistant, together with visually estimating the amount of blood loss. Once uterine atony or estimated blood loss (EBL) of more than 500 ml is noticed, another uterotonics will be administered according to the condition and at the discretion of the obstetrician.
Failure to achieve adequate uterine contraction and to control post partum hemorrhage (PPH) by the routine uterine massage will urge the use of either different uterotonics or surgical intervention if necessary. Blood transfusion will be ordered for the cases whose visual estimation of blood loss is more than 1000ml or when the patient was hemodynamically unstable. In order to compare the effect of each medication alone on the amount of blood loss, we will then exclude those patients who received blood transfusion or additional uterotonics. A base line hemoglobin and hematocrit levels will be withdrawn on admission and another reading 12 hours postpartum.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Misoprostol | Experimental | Drug: Misoprostol after delivery, Drug: Oxytocin before deliveryRectal misoprostol |
| Oxytocin | Experimental | Drug: Oxytocin after delivery, Drug: Oxytocin before deliveryintravenous oxytocin |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women with single viable pregnancy,
- cephalic presentation,
- at full term
- whom labor was induced by Oxytocin were eligible
Key exclusion criteria (2 listed)
- delivery by cesarean section
- received other prophylactic uterotonics
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 after deliveryPatients will receive 1000 mcg Misoprostol per rectum | Drug | Misoprostol |
| Oxytocin after deliveryPatients will receive 20 units oxytocin intravenously in one liter of Lactated Ringer solution at a rate of 150ml/h | Drug | Oxytocin |
| Oxytocin before deliveryAll patients will receive oxytocin 0.5-1 milliUnit/min IV, titrated to 1-2 milliUnit/min every 15-60 min before delivery to induce labor | Drug | Misoprostol, Oxytocin |
Primary outcome
Hemoglobin level
Time frame: 12 to 24 hours post partum
10% or more drop in hemoglobin
4 secondary outcomes
mean hemoglobin drop
Time frame: 12 to 24 hours post partum
mean estimated blood loss
Time frame: during the first hour post partum
drop in hemoglobin
Time frame: 12 to 24 hours post partum
side effect of medication
Time frame: upto 48 hours after delivery
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 16 Jan 2018.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Misoprostol after delivery, Oxytocin after delivery and Oxytocin before delivery in people with Prevention of Post Partum Hemorrhage After Labor Induction, run by Makassed General Hospital at 1 site in Lebanon.
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 2 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 16 Jan 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 Lebanon. 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?
Hemoglobin level (time frame: 12 to 24 hours post partum). 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 16 Jan 2018.