Healthy women immediately after a spontaneous delivery MedDRA version: 9.1 Level: HLT Classification code 10029772
Conditions
Interventions
Trade Name: METHERGIN
Pharmaceutical Form: Oral drops, emulsion
INN or Proposed INN: Methylergometrine
Concentration unit: 1X 100 milligrams/millilitre
Concentration type: equal
Concentration number:
Sponsors
UNIVERSITA` DEGLI STUDI DI NAPOLI FEDERICO II
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Signature of informed consent Age between 18 and 35 years Spontaneous, non operative, delivery Singleton, uneventful pregnancy Gestational age between 37 and 40 weeks Fetal weight between 2800 and 3800 g Haemoglobin levels before delivery greater than 10 g/dl Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Contraindications to ergot alkaloids (hypertension and cardiovascular diseases) Pregnancy related diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Difference between treatment and placebo groups in haemoglobin levels variation from the time of delivery to the tenth postpartum day;Secondary Objective: Difference between treatment and placebo groups in the uterine volume variations from time of delivery to the tenth postpartum day; Difference between treatment and placebo groups in the presence of signs of endometritis during the ten days of treatment;Primary end point(s): Difference between treatment and placebo groups in haemoglobin levels variation from the time of delivery to the tenth postpartum day | — |
Countries
Italy
Outcome results
None listed