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Completed

NCT Number: NCT02983591

Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin

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.

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Key information

Conditions

Prevention of Post Partum Hemorrhage After Labor Induction

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Makassed General Hospital

Beirut, Lebanon

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • women with single viable pregnancy,
  • cephalic presentation,
  • at full term
  • whom labor was induced by Oxytocin were eligible

Exclusion criteria

  • delivery by cesarean section
  • received other prophylactic uterotonics

Treatment and study plan

Misoprostol after delivery

Drug

Patients will receive 1000 mcg Misoprostol per rectum

Oxytocin after delivery

Drug

Patients will receive 20 units oxytocin intravenously in one liter of Lactated Ringer solution at a rate of 150ml/h

Oxytocin before delivery

Drug

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

Primary outcomes

  1. Hemoglobin level

    Time frame: 12 to 24 hours post partum

    10% or more drop in hemoglobin

Secondary outcomes

  1. mean hemoglobin drop

    Time frame: 12 to 24 hours post partum

    difference between pre and post partum hemoglobin levels

  2. mean estimated blood loss

    Time frame: during the first hour post partum

    visual estimation of blood loss

  3. drop in hemoglobin

    Time frame: 12 to 24 hours post partum

    2g/dl drop in hemoglobin

  4. side effect of medication

    Time frame: upto 48 hours after delivery

    fever > 38°C, diarrhea, and shivering

Sponsors and collaborators

Lead sponsor

Makassed General Hospital

Other

Registry information

Official study title

Effect of Misoprostol in Reducing Post Partum Hemorrhage After Labor Induction by Oxytocin: a Prospective Randomized Controlled Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Dec 6, 2016
Registry last updated
Jan 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.