Health TrialsbyHealthPanel

Sublingual Oxytocin for the Prevention of Post-partum Hemorrhage

ConditionPost Partum Hemorrhage
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-40
SponsorInsud Pharma

About this trial

An open-label, randomized, single-center, dose ascending trial will be conducted to evaluate the efficacy and safety of sublingual oxytocin for the prevention of post-partum hemorrhage caused by uterine atony in term pregnant women having an uncomplicated vaginal delivery.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Women willing and able to provide Informed consent.

Women who are able to understand, confirm and give informed consent during an antenatal visit or first stage of labor (cervical dilation <6 cm).

Healthy, primiparous or multiparous (2-4 deliveries), term-pregnant female with a gestational age of 37 to 42 weeks (inclusive). Gestational age should be confirmed with an obstetrical ultrasound if available.

Aged between 18 and 40 years (both inclusive).

Disqualifiers

Women who are unable to provide written Informed consent.

Women undergoing an elective or emergency cesarean section.

Conditions predisposing to uterine atony and PPH (e.g., previous PPH, placenta praevia, multiple gestation, severe pre-eclampsia, polyhydramnios, uterine fibroids, need for induction of labor, bleeding diathesis, sepsis, body mass index [BMI] ˃ 30 kg/m2 , macrosomia with estimated fetal weight >4500 g, if antenatal ultrasound was performed).

Women with moderate or severe anemia (defined as Hb <10 g/dL).

Trial design

Design model

Parallel

Treatments tested in this trial

  • Oxytocin sublingual

    Drug

    Sublingual oxytocin 1000 IU, 3000 IU or 6000 IU

  • Oxytocin IM

    Drug

    Intramuscular oxytocin 10 IU

Treatment groups

330 Participants
are divided into 2 treatment groups
Group A: Sublingual OxytocinExperimental treatment 1 intervention
Group B: Intramuscular OxytocinOther 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants with a satisfactory uterine tone and cumulative blood loss < 500 ml

Time frame
From administration of the drug to 20 minutes post-partum

Secondary outcomes

1

Proportion of participants with satisfactory uterine tone

Time frame
after 3 min, 5 min, 10 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 12 hours and 24 hours after administration of the drug
2

Measurement of blood loss

Time frame
3 min, 5 min, 10 min, 15 min, 30 min, 1 hour, 2 hours, 4 hours, 12 hours and 24 hours after administration of the drug
3

Proportion of participants who develop primary PPH

Time frame
Up to 24 hours after administration of the drug
4

Incidence of blood transfusion due to PPH

Time frame
At 24 hours after administration of the drug

Other outcomes

Sponsors and contacts

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

Insud Pharma

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: