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Completed

NCT Number: NCT02405663

Methods of Placental Delivery and the Amount of Blood Loss During Cesarean Section

To compare between the effect of controlled cord traction and manual removal of the placenta on blood loss among women undergoing caesarean sections

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Key information

Age range

20 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Postpartum ward of Armed Forces Hospital, Southern Region

Khamis Mushait, 'Asir Region, 101, Saudi Arabia

About this study

Cesarean section (CS) is one of the most commonly performed major abdominal operations in women worldwide and its rate is increasing dramatically every year.

Some of the reported short-term morbidities include hemorrhage, postoperative fever and endometritis. The method of delivering the placenta is one procedure that may contribute to an increase or decrease in the morbidity of CS.

On an average 0.5-1 liter of blood is lost during CS, many variable techniques have been tried to reduce this blood loss. Such techniques include finger splitting versus scissor cutting of incision, in situ stitching verses exteriorization and stitching of uterus , and finally spontaneous or manual removal of the placenta.

Two common methods used to deliver the placenta at CS are cord traction and manual removal.

Manual removal of the placenta which the obstetrician introduce his hand into the uterine cavity to cleave the placenta from the decidua basalis as soon as possible after the delivery of the infant and controlled cord traction in which the obstetrician do external uterine massage and gentle traction on the exposed umbilical cord to facilitate placental delivery.

Opinions differ about the best for placental delivery technique at CS. Some trials showed a reduced risk of blood loss with controlled cord traction (3) and others showed that manual removal of placenta at CS do not increase perioperative blood loss.

Authors concluded that manual delivery of the placenta was significantly associated with greater operative blood loss and greater decrease in postoperative hemoglobin levels and postpartum maternal infectious morbidity but with shorter operative time compared with spontaneous placental separation .

In addition, it is known that the blood loss at CS delivery is difficult to estimate, and numerous different methods including serial change in hematocrit (Hct), hemoglobin (Hb) level, visual estimation and the gravimetric method are described.

A low, but significant, correlation was found between visually estimated blood loss and perioperative hemoglobin change in women delivering by CS. However, hemoglobin , hematocrit levels and visual estimation are the most commonly used technique for estimating blood loss at delivery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • All informed and consented women undergoing elective or emergency CS will be legible for enrollment into the study

Exclusion criteria

  • Multiple gestation.
  • Pregnancy below 34 weeks.
  • Severe maternal anemia.
  • Severe pre-eclampsia
  • Prolonged labor.
  • Prolonged rupture of the membranes with fever.
  • Placental abruption.
  • Placenta previa.
  • Placenta accreta.
  • Clotting disorders.
  • Current or previous history of a significant disease including heart disease, liver, renal disorders.

Treatment and study plan

manual removal

Procedure

one of the standard procedures for placental delivery during caesarean section the surgeon will introduce his hand into the uterine cavity to cleave the placenta from the decidua basalis as soon as possible after the delivery of the baby

cord traction

Procedure

one of the standard procedures for placental delivery during caesarean section the surgeon do external uterine massage and gentle traction on the exposed umbilical cord to facilitate placental delivery

Primary outcomes

  1. blood loss assessment after placental delivery

    Time frame: 12 hours

    Determine estimated blood loss after placental delivery either by cord traction or manually during caesarean section through comparing pre and postoperative hemoglobin and haematocrit measurements

Secondary outcomes

  1. Placental delivery time.

    Time frame: 30 minutes

    time needed to deliver the placenta calculated from time of full baby delivery to the time of full placental delivery

  2. Duration of operation

    Time frame: 2 hours

    time calculated from first skin incision to the time of last stitch

  3. Need to use ecbolics

    Time frame: 30 minutes

    documentation of the type, the dose of different ecbolics needed to stop any possible bleeding

  4. Need of blood transfusion

    Time frame: 12 hours

    documentation of the need and the amount needed of packed red blood cells packs or any other blood products if patient general condition required

  5. Blood loss > 1000 ml

    Time frame: 12 hours

    counting down the cases of estimated blood loss more than 1000ml

  6. postoperative endometritis and puerperal pyrexia

    Time frame: one week

    counting down the cases of puerperal pyrexia after exclusion of all other etiologies rather than endometritis

Sponsors and collaborators

Lead sponsor

Benha University

Other

Collaborators

  • Armed Forces Hospitals, Southern Region, Saudi Arabia

Registry information

Official study title

How Can Methods of Placental Delivery Affect the Amount of Blood Loss During Cesarean Section?

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 1, 2015
Registry last updated
May 30, 2017

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.

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