Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy

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Samuel Lunenfeld Research Institute, Mount Sinai Hospital

ASSAIG CLÍNIC: NCT04025658

BioSeek: nct04025658

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Resum

Postpartum hemorrhage (PPH) due to uterine atony is a major cause of maternal morbidity and mortality. Uterotonic drugs are used to improve the muscle tone of the uterus after birth and these are effective at reducing the incidence of PPH. Large doses of this drug are associated with adverse effects like lower blood pressure, nausea, vomiting, abnormal heart rhythms and changes on ECG. Various international bodies recommend varying and high doses of oxytocin in elective cesarean sections. A study performed at Mount Sinai Hospital showed that a much smaller doses of oxytocin is required (ED95 being 0.35IU). Women who had twins were excluded from this study. It is known that women with a twin pregnancy have a higher risk of poor tone and postpartum hemorrhage.

The investigators seek to find the best dose of oxytocin for the patients with a twin pregnancy. A higher dose may be needed to contract the uterus adequately.

Descripció

Postpartum hemorrhage (PPH) is one of the leading causes of death during childbirth and accounts for an estimated 140,000 deaths per year worldwide. Furthermore, recent evidence has shown that the rate of PPH secondary to uterine atony is increasing.

Multiple pregnancy is a well-recognized risk factor for PPH. Compared with singleton pregnancy, women with a multiple pregnancy have an increased risk of PPH, severe PPH, transfusion, uterine atony, hysterectomy, prolonged hospital stay and death. This is true in both high- and low-income countries. Uterine atony as a cause of PPH is more likely in multiple pregnancy compared with singleton pregnancy.

Prophylactic uterotonic drugs administered after the delivery have been demonstrated to reduce the incidence of PPH by up to 40%. Oxytocin is the most commonly administered uterotonic drug used to prevent PPH in North America but is associated with adverse effects such as hypotension, nausea, vomiting, dysrhythmias, ST segment abnormalities, and severe water intoxication that may lead to pulmonary edema and convulsions.

Previous dose finding studies have excluded women with twin pregnancies. Therefore, the investigators wish to perform a double blinded dose finding study using the biased coin flip up-and-down sequential allocation technique to determine the ED 90 of oxytocin at cesarean section in those women with a twin pregnancy.

Dates

Darrera verificació:	02/29/2020
Primer enviat:	07/16/2019
Inscripció estimada enviada:	07/16/2019
Publicat per primera vegada:	07/18/2019
Última actualització enviada:	03/18/2020
Publicació de l'última actualització:	03/19/2020
Data d'inici de l'estudi real:	08/05/2019
Data estimada de finalització primària:	11/30/2020
Data estimada de finalització de l’estudi:	11/30/2020

Condició o malaltia

Postpartum Hemorrhage

Twin

Intervenció / tractament

Drug: Oxytocin

Fase

Grups de braços

Braç	Intervenció / tractament
Active Comparator: Oxytocin 0.5IU Patient is given 0.5IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Active Comparator: Oxytocin 1IU Patient is given 1IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Active Comparator: Oxytocin 2IU Patient is given 2IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Active Comparator: Oxytocin 3IU Patient is given 3IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Active Comparator: Oxytocin 4IU Patient is given 4IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.
Active Comparator: Oxytocin 5IU Patient is given 5IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.

Criteris d'elegibilitat

Edats elegibles per estudiar	18 Years Per a 18 Years
Sexes elegibles per estudiar	Female
Accepta voluntaris saludables	Sí
Criteris	Inclusion Criteria: - Twin pregnancy - Elective cesarean delivery under regional anesthesia - Gestational age ≥36 weeks - No known additional risk factors for postpartum hemorrhage - Written informed consent to participate in this study Exclusion Criteria: - Refusal to give written informed consent - Allergy or hypersensitivity to oxytocin - Conditions that may predispose to uterine atony and postpartum hemorrhage such as placenta previa, severe preeclampsia (as defined by SOGC guidelines (25)), polyhydramnios, uterine fibroids, previous history of uterine atony resulting in PPH, or bleeding diathesis and obesity, defined as pre-pregnancy BMI >40 - Hepatic, renal, and vascular disease - Use of general anesthesia prior to the administration of the study drug

Resultat

Mesures de resultats primaris

1. Uterine tone 2 minutes: questionnaire [3 minutes]

Uterine tone, defined as satisfactory or unsatisfactory by the obstetrician at 2 minutes after completion of the oxytocin injection (3 minutes post delivery).

Mesures de resultats secundaris

1. Need for uterine massage: questionnaire [20 minutes]

The obstetricians will be asked if there was any need for uterine massage beyond the initial 3 minute evaluation period following delivery.

2. Intraoperative requirement for additional uterotonic medication [2 hours]

A request made by the obstetrician performing the cesarean delivery for additional uterotonic medication, due to bleeding or poor uterine tone.

3. Calculated estimate of blood loss [24 hours]

Blood loss will be calculated through the difference in hematocrit values assessed prior to and at the end of 48 hours after the cesarean delivery, according to the following formula: Calculated blood loss = EBV ((Pre-op Htc-Post-op Htc)/pre-op Htc). EBV (estimated blood volume) in ml: patient's weight in kg x 85

4. Intravenous fluid administered during surgery [2 hours]

The total volume (ml) of fluid administered from entering the operating room to skin closure.

5. Hypotension: systolic blood pressure less than 80% of baseline [2 hours]

Systolic blood pressure < 80% of baseline, from drug administration until end of surgery

6. Tachycardia: heart rate greater than 130% of baseline [2 hours]

Heart rate > 130% of baseline, from drug administration until end of surgery

7. Bradycardia: heart rate less than 70% of baseline [2 hours]

Heart rate < 70% of baseline or a heart rate < 50bpm, from drug administration until end of surgery

8. Presence of ventricular tachycardia: ECG [2 hours]

Presence of ventricular tachycardia as recorded by ECG, from drug administration until end of surgery

9. Presence of atrial fibrillation: ECG [2 hours]

Presence of atrial fibrillation as recorded by ECG, from drug administration until end of surgery

10. Presence of atrial flutter: ECG [2 hours]

Presence of atrial flutter as recorded by ECG, from drug administration until end of surgery

11. Presence of nausea: questionnaire [2 hours]

The presence of nausea and number of episodes, from drug administration until end of surgery, as reported by the patient

12. Presence of vomiting: questionnaire [2 hours]

The presence of vomiting and number of episodes, from drug administration until end of surgery

13. Presence of chest pain: questionnaire [2 hours]

Any presence of chest pain, from drug administration until end of surgery, as reported by the patient

14. Presence of shortness of breath: questionnaire [2 hours]

Any presence of shortness of breath, from drug administration until end of surgery, as reported by the patient

15. Presence of headache: questionnaire [2 hours]

Any presence of headache, from drug administration until end of surgery, as reported by the patient

16. Presence of flushing: questionnaire [2 hours]

Any presence of flushing, from drug administration until end of surgery

Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy

Paraules clau

nàusea

vòmit

hemorràgia

edema

seizures

edema pulmonar

hipotensió arterial

uterine inertia

hemorràgia postpart