The effect of naloxone-buprenorphine on the prevention of premature birth in opiate-addicted women

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20250507065634N1

Enrollment

Registered

2025-08-04

Start date

2025-09-01

Completion date

Unknown

Last updated

2025-08-19

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

Conditions

Preterm labor in pregnant women addicted to opium and evaluation of the effect of naloxone-buprenorphine on the efficacy of progesterone. Preterm labor

Interventions

Intervention 1: Control group: This group receives only routine prenatal care without any pharmaceutical intervention (no progesterone or naloxone-buprenorphine). Care is provided based on standard pr

Eligibility

Sex/Gender

Female

Age

20 Years to 35 Years

Inclusion criteria

Inclusion criteria: Pregnant women aged between 20 and 35 years Singleton pregnancy History of opium or its derivatives use for less than 10 years Positive addiction status confirmed by TLC test Signed informed consent for

Exclusion criteria

Exclusion criteria: Presence of gestational hypertension Multiple pregnancy History of preterm birth in previous pregnancies Uterine abnormalities such as short cervix Severe anemia History of surgery involving the uterus or cervix

Design outcomes

Primary

Measure	Time frame
Level of relaxin in maternal placental tissue. Timepoint: Immediately after delivery and placenta extraction. Method of measurement: Blood and tissue sampling from the human placenta and gene expression measurement using real-time PCR.;The expression level of the Connexin 43 gene in the maternal surface tissue of the placenta. Timepoint: Immediately after delivery and placenta extraction. Method of measurement: Blood and tissue sampling from the human placenta and gene expression measurement using real-time PCR.;The level of prolactin receptor in the placental tissue. Timepoint: Immediately after delivery and placenta extraction. Method of measurement: Blood and tissue sampling from the human placenta and gene expression measurement using real-time PCR.;The level of collagenase alpha-2 in the maternal surface tissue of the placenta. Timepoint: Immediately after delivery and placenta extraction. Method of measurement: Blood and tissue sampling from the human placenta and gene expression measurement using real-time PCR.;Prostaglandin F2 alpha (PGF2a). Timepoint: Immediately after delivery and placenta extraction. Method of measurement: ELISA kit for placental serum.;Level of CD44 in placental blood. Timepoint: Immediately after delivery and placenta extraction. Method of measurement: ELISA kit for placental serum.	—

Measure

Time frame

Level of relaxin in maternal placental tissue. Timepoint: Immediately after delivery and placenta extraction. Method of measurement: Blood and tissue sampling from the human placenta and gene expression measurement using real-time PCR.;The expression level of the Connexin 43 gene in the maternal surface tissue of the placenta. Timepoint: Immediately after delivery and placenta extraction. Method of measurement: Blood and tissue sampling from the human placenta and gene expression measurement using real-time PCR.;The level of prolactin receptor in the placental tissue. Timepoint: Immediately after delivery and placenta extraction. Method of measurement: Blood and tissue sampling from the human placenta and gene expression measurement using real-time PCR.;The level of collagenase alpha-2 in the maternal surface tissue of the placenta. Timepoint: Immediately after delivery and placenta extraction. Method of measurement: Blood and tissue sampling from the human placenta and gene expression measurement using real-time PCR.;Prostaglandin F2 alpha (PGF2a). Timepoint: Immediately after delivery and placenta extraction. Method of measurement: ELISA kit for placental serum.;Level of CD44 in placental blood. Timepoint: Immediately after delivery and placenta extraction. Method of measurement: ELISA kit for placental serum.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMaryam Kheirollahi

Kerman University of Medical Sciences

maryam.kheirollahi94@gmail.com-

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026