The influence of twin pregnancy on the kinetic disposition and crossing of the placental barrier of betamethasone

Pharmacokinetics and placental transfer studies of betamethasone in twin pregnancies

Status

Active, not recruiting

Phases

Phase 3

Study type

Observational

Source

REBEC

Registry ID

RBR-2v2mwkz

Enrollment

Unknown

Registered

2021-02-10

Start date

2018-03-31

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Betamethasone, pharmacokinetics, twin pregnancy, placental transfer, preterm labor, Preterm labor with preterm delivery, Pregnancy High-Risk

Interventions

Twenty-six adult pregnant women (18-35 years old), who were admitted to the Obstetric Center of HC-FMRP-USP for the inhibition of preterm labor, were investigated. After medical evaluation and with an

N04.452.706.477

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult women (> 18 years) with single or multiple pregnancies of morphologically normal fetuses, with gestational age between 24 - 34 weeks; risk of imminent prematurity and therefore, with an indication of antenatal administration of betamethasone to stimulate fetal maturity; normal biochemical and hematological parameters.

Exclusion criteria

Exclusion criteria: Smoking, alcoholism, and/or use of illegal substances; maternal diseases that develop vasculopathy and influence uteroplacental flow, such as hypertension, uncontrolled diabetes, heart disease, kidney disease, or thrombophilia; fetuses with congenital anomaly; injury identification in target organs by laboratory examination.

Design outcomes

Primary

Measure	Time frame
The data suggest that dichorionic twin (DC) presents greater differences in pharmacokinetic parameters when compared to the control and monochorionic twin group. AUC is significantly higher and CL / F is significantly lower (p = 0.01) in pregnant women with single fetuses compared between single and twin pregnancies. ;This study shows the influence of twinning on the pharmacokinetics of betamethasone, suggesting the presence of two placentas may enhance CYP3A4 metabolism and increase betamethasone elimination in dichorionic twin pregnancies in comparison to singleton pregnancies.	—

Measure

Time frame

The data suggest that dichorionic twin (DC) presents greater differences in pharmacokinetic parameters when compared to the control and monochorionic twin group. AUC is significantly higher and CL / F is significantly lower (p = 0.01) in pregnant women with single fetuses compared between single and twin pregnancies. ;This study shows the influence of twinning on the pharmacokinetics of betamethasone, suggesting the presence of two placentas may enhance CYP3A4 metabolism and increase betamethasone elimination in dichorionic twin pregnancies in comparison to singleton pregnancies.

—

Secondary

Measure	Time frame
In preliminary results, the evaluation of placental transfer of betamethasone also appeared to be affected by twinning, especially in DC twin pregnancies.;In preliminary results, the evaluation of placental transfer of betamethasone also appeared to be affected by twinning, especially in DC twin pregnancies.	—

Countries

Brazil

Contacts

Public ContactAlessandra Marcolin

Faculdade de Medicina de Ribeirão Preto

dralemar@uol.com.br+ 55 (16) 3602-2583

Outcome results

None listed

Source: REBEC (via WHO ICTRP)