Emergency Contraception
Conditions
Keywords
ella, ulipristal acetate, pregnancy, emergency contraception
Brief summary
The study is aimed at assessing the clinical follow-up and the outcomes of pregnancies exposed to ella, whether due to failure of the emergency contraception or inadvertent exposure during pregnancy.
Interventions
DRUGella
ella, single intake, tablet 30mg
Sponsors
HRA Pharma
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Pregnant women, exposed to ella during the menstrual cycle in which the pregnancy started (treatment failure) or at any time during pregnancy (inadvertent exposure during pregnancy) * Adolescents and/or adults in the USA, depending on the respective State law
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experienced Assessed Pregnancy Outcomes | up to 9 months after pregnancy diagnosis | Live birth outcomes: Healthy baby; Congenital anomaly: a baby born with a congenital anomaly; Neonatal death: a newborn who died during the first 28 days of life; Preterm birth: a baby born at less than 37 weeks of gestational age; Pregnancy loss outcomes: Ectopic pregnancy: implantation of the fertilized egg and pregnancy development in a location outside the uterus and attempt to develop in this location; Spontaneous abortion: early fetal death (i.e. less than 20 completed weeks of gestation); Fetal death: Intermediate fetal death (between greater than 20 and less than 28 completed weeks of gestation); Late fetal death (greater or equal to 28 completed weeks of gestation); Induced abortions can be either: An induced abortion for non-medical reason; An induced abortion for medical reasons (termination of pregnancy for fetal anomaly, or for other pregnancy or maternal health complications) |
Countries
United States
Participant flow
Recruitment details
Ella-exposed pregnant women were recruited either by Health Care Professionals at Family Planning Clinics or through web-based self enrollment between November 2014 and December 2017. The first participant was enrolled on November 18, 2014 and the last participant was enrolled December 12, 2017.
Participants by arm
| Arm | Count |
|---|---|
| Ella ella: ella, single intake, tablet 30mg | 98 |
| Total | 98 |
Baseline characteristics
| Characteristic | Ella | — |
|---|---|---|
| Age, Continuous | 26.6 years STANDARD_DEVIATION 5.5 | — |
| Body Mass Index | 26.7 kg/m^2 STANDARD_DEVIATION 5.3 | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 98 Participants | — |
| Sex: Female, Male Female | 98 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Number of Participants Who Experienced Assessed Pregnancy Outcomes
Live birth outcomes: Healthy baby; Congenital anomaly: a baby born with a congenital anomaly; Neonatal death: a newborn who died during the first 28 days of life; Preterm birth: a baby born at less than 37 weeks of gestational age; Pregnancy loss outcomes: Ectopic pregnancy: implantation of the fertilized egg and pregnancy development in a location outside the uterus and attempt to develop in this location; Spontaneous abortion: early fetal death (i.e. less than 20 completed weeks of gestation); Fetal death: Intermediate fetal death (between greater than 20 and less than 28 completed weeks of gestation); Late fetal death (greater or equal to 28 completed weeks of gestation); Induced abortions can be either: An induced abortion for non-medical reason; An induced abortion for medical reasons (termination of pregnancy for fetal anomaly, or for other pregnancy or maternal health complications)
Time frame: up to 9 months after pregnancy diagnosis
Population: Pregnancy outcomes were described for pregnancies with known outcome (patients with missing outcomes and patients lost to follow-up were excluded from the descriptive analyses).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ella | Number of Participants Who Experienced Assessed Pregnancy Outcomes | Induced Abortions for non-medical reasons | 93 Participants |
| Ella | Number of Participants Who Experienced Assessed Pregnancy Outcomes | Healthy Live Births | 1 Participants |
| Ella | Number of Participants Who Experienced Assessed Pregnancy Outcomes | total prevalence congenital anomalies | 0 Participants |
| Ella | Number of Participants Who Experienced Assessed Pregnancy Outcomes | Ectopic Pregnancies | 1 Participants |
| Ella | Number of Participants Who Experienced Assessed Pregnancy Outcomes | Spontaneous abortion | 0 Participants |
| Ella | Number of Participants Who Experienced Assessed Pregnancy Outcomes | Fetal Deaths | 0 Participants |
| Ella | Number of Participants Who Experienced Assessed Pregnancy Outcomes | Induced Abortions for medical reasons | 0 Participants |
| Ella | Number of Participants Who Experienced Assessed Pregnancy Outcomes | Maternal Deaths | 0 Participants |