Current partner codePEPTIDESDE
NCT05503927·Not applicable·OBSERVATIONAL

A Study to Evaluate the Safety of Exposure to Wegovy During Pregnancy

Status

Enrolling by invitation

Phase

Not applicable

Enrollment

2,701

Locations

2

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

This is an observational cohort study using administrative insurance claims data. The aim of this non-interventional study (NIS) is to compare maternal, fetal and infant outcomes of women exposed to Wegovy during pregnancy to a reference population not exposed to Wegovy, so that participants and healthcare providers can make informed treatment decisions.

Interventions

Treatment arms and agents.

OTHER

No Intervention

This is a non-interventional study, therefore no intervention is used.

Timeline

From registration to results.

  1. First posted

    Aug 17, 2022

  2. Study start

    Feb 1, 2020

  3. Primary completion

    Aug 15, 2027

  4. Study completion

    Aug 15, 2027

  5. Results posted

    Not reported

  6. Registry updated

    Jul 21, 2026

Outcomes

What the study measures.

Primary outcomes

Number of Infants with Major Congenital Malformation (MCM)

Time frame · Birth up to 1 year of age

Number of infants with MCM is defined as an abnormality of body structure or function that is present at birth, is of prenatal origin (that is, birth defect), has significant medical, social, or cosmetic consequences for the affected individual, and typically requires medical intervention.

Secondary outcomes

Number of Infants Experiencing Small for Gestational Age (SGA) Birth

Time frame · Birth up to 1 year of age

Number of infants experiencing small for gestational age is defined as weight at birth in less than (\<) 10th percentile for sex and gestational age using standard growth charts for full and preterm live born infants.

Number of infants with Developmental Delay

Time frame · Birth up to 1 year of age

Infant development delay will be defined as infants with evidence of one or more of the following outcomes in the first year of life: delayed milestone in childhood, other lack of normal physiological development, special screening for developmental disabilities.

Number of Infants With Postnatal Growth Deficiency

Time frame · Birth up to 1 year of age

Number of infants with adverse postnatal growth will be defined as infants with evidence of the following outcomes in the first year of life: abnormal weight gain (insufficient or excessive weight gain), short stature, failure to thrive.

Number of Pregnant Participants Experiencing Stillbirth

Time frame · up to 37 weeks of gestational age

Number of pregnant participants experiencing still birth is defined as an involuntary fetal loss occurring at greater than or equal to (\>=20) WGA.

Number of Pregnant Participants Experiencing Spontaneous Abortion (SAB)

Time frame · up to 37 weeks of gestational age

Number of pregnant participants experiencing SAB is defined as an involuntary fetal loss or the expulsion of the products of conception occurring at \<20 WGA.

Number of Pregnant Participants With Preterm Delivery

Time frame · Up to 37 weeks of gestational age

Preterm birth is defined as a live birth occurring at \<37 WGA.

Number of Pregnant Participants With Pre-eclampsia/eclampsia

Time frame · Up to 37 weeks of gestational age

Pre-eclampsia/eclampsia is defined as new onset of hypertension with proteinuria occurring at \>=20WGA through the six weeks following pregnancy end.

Eligibility

Who can take part.

Minimum age
15 Years
Maximum age
50 Years
Sex
FEMALE
Healthy volunteers
Not reported

Inclusion Criteria: * Evidence of a pregnancy end event on a medical claim (example, live birth, stillbirth, or spontaneous abortion) during the pregnancy identification period (that is, 04 June 2021 - 17 February 2034). * Date of conception between 04 June 2021 and 06 May 2033 (that is last menstrual period (LMP) 43 weeks prior to the latest pregnancy end date). * Aged 15-50 and female on the date of the LMP. * Continuous enrolment in the database with medical and pharmacy benefits for at least 6 months prior to the date of conception through 42 days after the pregnancy end date. * Among the pregnancies that meet the inclusion criteria, four main cohorts and two sub cohorts of interest will be identified (two Wegovy-exposed cohorts and two comparison cohorts): * Wegovy-exposed- for greater than or equal to 1 day of Wegovy exposure from 35 days prior to estimated date of conception to end of pregnancy. Two mutually exclusive cohorts will be identified based on first Wegovy exposure during pregnancy. 1. Wegovy injection-exposed- for greater than or equal to 1 day of Wegovy exposure from 35 days prior to estimated end of pregnancy. 2. Wegovy tablet-exposed- for greater than or equal to 1 day of Wegovy exposure from 35 days prior to estimated end of pregnancy. * Other AOM-exposed- greater than or equal to1 day of phentermine, diethylpropion, benzphetamine, phendimetrazine, orlistat, or bupropion/naltrexone exposure, defined as the following: * Benzphetamine, diethylpropion, orlistat, or phendimetrazine exposure from one day prior to estimated conception date to end of pregnancy. * Phentermine or bupropion/naltrexone exposure from five days prior to estimated conception date to end of pregnancy. * Cohort with Overweight/Obesity and at least one weight related comorbid condition- * Greater than or equal to 1 diagnosis code for obesity or BMI greater than or equal to 30 kilogram per meter square (kg/m\^2) on a medical claim during the six month pre-pregnancy period. * Greater than or equal to 1 diagnosis code for BMI greater than or equal to 27 kg/m\^2 or less than 30 kg/m\^2 on a medical claim and greater than or equal to 1 non-diagnostic medical claim for dyslipidemia, type 2 diabetes mellitus, or hypertension during the six month pre-pregnancy period. * No exposure to Wegovy or other AOM during the defined exposure window in pregnancy. * Among Wegovy-exposed and Other AOM-exposed pregnancies, the subset with first trimester exposures will be identified as those with greater than or equal to 1 days of exposure at less than 14 WGA. Exclusion Criteria: * Pregnancies exposed to other glucagon-like peptide-1 receptor agonist (GLP-1 RA) during the exposure identification window (that is, 35 days prior to estimated conception date through pregnancy end date). * Pregnancies with exposure to both Wegovy and other AOM during the exposure identification window (estimated conception date - 35 days through pregnancy end date). * Pregnancies resulting in multiple infants will be excluded from the analysis of infant outcomes.

Study locations

2 registered sites.

United States. Showing up to 24 locations stored in the fast local snapshot.

IBM Watson Health™ Truven Marketscan

Ann Arbor, Michigan, United States

Novo Nordisk Investigational Site

Princeton, New Jersey, United States

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

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