Health TrialsbyHealthPanel

Maternal Outcomes Following Manual Lysis of the Placenta.

ConditionThird Stage of Delivery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorHoly Family Hospital, Nazareth, Israel

About this trial

Comparison of maternal outcomes following manual lysis of placenta 15 vs 30 minutes after delivery. A primary outcome of the drop in hemoglobin will be compared between the two groups. Secondary outcomes include blood transfusion rate, maternal satisfaction, time to first breastfeeding, length of hospital stay, infection rate etc.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Term spontaneous vaginal delivery.

Singleton Pregnancy.

Epidural Analgesia during delivery.

Age between 18 and 45 years.

Disqualifiers

Active bleeding after delivery that warrants prompt removal of placenta regardless of time from delivery.

Vacuum Extraction.

Intrapartum Infection.

Intrapartum fever above 38 degrees celsius.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Manual Lysis of Placenta after 15 minutes (Intervention)

    Procedure/Surgery

    Manual Lysis of Placenta after 15 minutes: We administer prophylactic antibiotics, under epidural analgesia, under aseptic conditions, we perform manual lysis of placenta by introducing the hand through the vagina to the uterine cavity, separating and removing the placenta.

  • Manual Lysis of Placenta after 30 minutes (Control)

    Procedure/Surgery

    Manual Lysis of Placenta after 30 minutes: We administer prophylactic antibiotics, under epidural analgesia, under aseptic conditions, we perform manual lysis of placenta by introducing the hand through the vagina to the uterine cavity, separating and removing the placenta.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Manual Lysis after 15 minutes (Intervention)Experimental treatment 1 intervention
Group B: Manual lysis after 30 minutes (Control)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Hemoglobin Drop

The difference between Hemoglobin levels before and after delivery

Time frame
within 24 hours after delivery

Secondary outcomes

1

Rate of Blood Products Given

Number and type of blood products given peripartum

Time frame
7 days
2

Blood Loss

Calculation of estimated blood loss during delivery by accepted formulas

Time frame
7 days
3

Febrile morbidity

Rate of developing fever after delivery

Time frame
within one week of delivery
4

First Nursing

Time until first breastfeeding

Time frame
7 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Holy Family Hospital, Nazareth, Israel

Lead sponsor

Source ClinicalTrials.gov
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