Fetal malformations following progesterone therapy during pregnancy: a preliminary report

John A. Rock; Anne Colston Wentz; Karen A. Cole; Allyn W. Kimball Jr; Howard A. Zacur; Sheila A. Early; Georgeanna Seegar Jones

doi:10.1016/s0015-0282(16)48670-x

Pregnancy Fetal Medicine

Fetal malformations following progesterone therapy during pregnancy: a preliminary report

Rock JA, Wentz AC, Cole KA, Kimball AW Jr, Zacur HA, Early SA, Jones GS

Published July 1985 Fertility and Sterility, 44(1), 17-19

DOI 10.1016/s0015-0282(16)48670-x PMID 4007191

RRM Academy Synopsis

Two term babies had anomalies among 93 progesterone pregnancies

A Johns Hopkins review found two term babies with birth defects among 93 progesterone-treated pregnancies. This case series reviewed hospital records from 1949 to 1977. Both babies were born to women given progesterone in oil. Miscarriage occurred in 12 of 42 pregnancies treated with suppositories.

Study at a glance, case series of 93 women: Two term babies had anomalies among 93 progesterone-treated pregnancies. Source: Rock JA et al., 1985, PMID 4007191.

Key Findings

The review covered 93 women who conceived while taking progesterone: 42 used suppositories and 51 received progesterone in oil by injection.
Two term babies had congenital anomalies: one had an undescended testis and one had a meningomyelocele. Both mothers had received progesterone in oil.
No woman treated with progesterone suppositories gave birth to a baby with a malformation.
Spontaneous abortion occurred in 12 of 42 pregnancies (28.6%) treated with suppositories and in 3 of 51 (5.8%) treated with progesterone in oil.
Follow-up averaged 6.8 years and ranged from birth to 30 years. For some of the children, information was available only at birth.

Interpretation

The authors report no increase in malformation risk among the babies born in this series. Most women in the suppository group who miscarried had been treated for less than 1 month for threatened abortion. The authors call this less than ideal therapy. They call for a national registry to track outcomes. The findings support larger studies of this approach.

RRM Context

The women had threatened abortion, low progesterone or repeat pregnancy loss. The authors kept natural progesterone separate from synthetic progestin drugs. RRM readers can treat this as an early safety record.

Our editorial summary of this paper, not the article's abstract.

Abstract

This report presents the outcome of pregnancies of 93 women who conceived while taking progesterone (P) suppositories (n = 42) or P in oil intramuscularly (n = 51). The dosage and duration of treatment varied according to the indication. The total dose (in milligrams) increased with the duration of treatment and ranged from 75 to 13,500 mg. Two of 75 term pregnancies (2.6%) were noted to have congenital anomalies. Both women had been treated with P in oil. No patient treated with P suppositories gave birth to a malformed infant. An increased spontaneous abortion rate (28.6%) was noted among women treated with P suppositories. The authors recommend that a national registry be created to document fetal outcome after P therapy.

Topics

Pregnancy › Fetal Medicine › Congenital Anomalies · Therapeutics › Hormonal Agents › Progesterone and Progestins · Reproductive Endocrinology › Ovarian Hormones › Progesterone

John A. Rock, Anne Colston Wentz, Karen A. Cole, Allyn W. Kimball Jr, Howard A. Zacur, Sheila A. Early, Georgeanna Seegar Jones

Jack Rock, J Rock, A Wentz, K Cole, A Kimball, H Zacur, S Early, G Jones

PMID 4007191 4007191 DOI 10.1016/s0015-0282(16)48670-x 10.1016/s0015-0282(16)48670-x Rock et al. 1985, Rock 1985

Keywords

Abnormalities, Drug-Induced, Abortion, Spontaneous/chemically Induced, Adult, Dose-Response Relationship, Drug, Emulsions, Female, Humans, Pregnancy, Progesterone/administration & Dosage/adverse Effects, Progesterone Congeners/administration & Dosage/adverse Effects, Suppositories, Emulsions, Progesterone Congeners, Suppositories, Progesterone

Fetal malformations following progesterone therapy during pregnancy: a preliminary report

Two term babies had anomalies among 93 progesterone pregnancies

Key Findings

Interpretation

RRM Context

Abstract

Topics

By this author

Related research

Keywords