Pregnancy and Childbirth Postpartum Hemorrhage
Conditions
Interventions
Oxytocin Sublingual tablets
Intramuscular Oxytocin injection
Sponsors
Chemo Research S.L
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women willing and able to provide Informed consent. 2. Women who are able to understand, confirm and give informed consent during an antenatal visit or first stage of labor (cervical dilation <6 cm). 3. 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. 4. Aged between 18 and 40 years (both inclusive). 5. Confirmed singleton pregnancy. 6. Based on the Investigator assessment, maternal and fetal conditions are met to expect a vaginal delivery. 7. For participants in the PK subgroup: women with baseline hemoglobin level =11 g/dL.
Exclusion criteria
Exclusion criteria: 1.Women unable to provide written Informed consent 2.Women undergoing an elective or emergency cesarean section 3.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]?30kg/m2 , macrosomia with estimated fetal weight >4500g, if antenatal ultrasound was performed) 4.Women with moderate/severe anemia (Hb<10g/dL) 5.Women who have undergone female genital mutilation 6.Known allergies to carbetocin, other oxytocin homologues or excipients in medicinal products used in the trial 7.Oral conditions before administration of sublingual oxytocin such as moderate erythema and edema, severe irritation/inflammation, moderate or severe abrasion 8.Conditions predisposing to myocardial ischemia due to pre-existing cardiovascular diseases (such as hypertrophic cardiomyopathy, valvular heart disease and/or ischemic heart disease, including vasospasm of the coronary arteries) or known long QT syndrome or related symptoms 9.Any clinically significant abnormality following review of medical history, laboratory result and physical examination at screening as judged by the Investigator (e.g., severe anemia, antepartum hemorrhage, mental disorder, history of cervical cancer or history of severe infection of the uterus, religious beliefs prohibiting blood transfusions) 10.Previous surgery of the cervix or uterus or any other (previous) condition that could interfere with the measurement of uterine contractility 11.Present use or use within 30 days before the start of IMP/reference product of one or more of the following: Antihypertensive drugs; Anti-coagulant therapy; Medications that could affect myometrial contractility; Sex steroids: progesterone; Prostaglandins and its analogues; Inhalation anaesthetics, vasoconstrictors/sympathomimetics and caudal anaesthetics; Medications known to prolong QT interval
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Proportion of participants with a satisfactory uterine tone and cumulative blood loss < 500 ml at 20-minutes after administration of the drug. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy: 1.Proportion of participants with satisfactory uterine tone 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 (ml) with a calibrated drape after 3 min, 5 min, 10 min, 15 min, 30 min, 1 hour, 2 hours after administration of the drug while the participant is in the labor ward. Afterwards, blood-soaked pads and swabs will be weighted continuously from 2 to 24 hours (at 4 hours, 12 hours and 24 hours as cutoff points) after administration of the drug to quantify the blood loss. 3.Proportion of participants who develop of primary PPH (defined as blood loss = 500 ml) up to 24 hours after administration of the drug. 4.Proportion of participants who develop sPPH (defined as blood loss = 1,000 ml) up to 24 hours after administration of the drug. 5.Change in hematological parameters from baseline to 24 hours after administration of the drug. 6.Incidence of blood transfusion due to PPH at 24 hours after administration of the drug. 7.Incidence of laparotomy for the treatment of PPH at 24 hours after administration of the drug. 8.Proportion of participants that achieve cessation of active bleeding within 20 minutes after administration of the drug. 9.Time to PPH onset (blood loss larger than 500 ml). 10. Time to active bleeding cessation.;Safety: Incidence and severity of Adverse Events (AEs) and Serious Adverse Events (SAEs).;Exploratory: 1. Measurement of pharmacokinetic parameters. 2. Investigate the relationship between oxytocin exposure (Cmax/AUC) and clinical outcomes, including uterine tone, bleeding, PPH timing, blood loss, and secondary endpoints over 4 hours postpartum. | — |
Countries
Nigeria
Contacts
Public ContactAlicyoy Angulo
Chemo Research SL
Outcome results
None listed