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The effect of early administration of rectal progesterone in IVF/ICSI twin pregnancies on the preterm birth rate: a randomized trial.
BMC Pregnancy Childbirth. 2020 Jun 09; 20(1):351.BP

Abstract

BACKGROUND

The rate of multiple pregnancies in IVF/ICSI ranges from 20 to 30%. The incidence of preterm birth in multiple pregnancies is as high as 60% and is even higher in pregnancies conceived after IVF & ICSI. The effect of progesterone on prevention of preterm birth in twins is controversial. Our group has proven a positive effect in reduction of preterm birth, by starting progesterone from the mid-trimester, in exclusively IVF/ICSI singleton pregnancies but not twins. The purpose of our current study was to explore the effect of earlier administration of natural progesterone, in IVF/ICSI twin pregnancies starting at 11-14 weeks for prevention of preterm birth.

METHODS

This is a double-blind, placebo controlled, single center, randomized clinical trial. Women with dichorionic twin gestations, having an IVF/ICSI trial were randomized to receive natural rectal progesterone (800 mg daily) vs placebo, starting early from 11 to 14 weeks. They also received oral and vaginal antimicrobial agents as part of our routine treatment for vaginitis and urinary tract infection. They were randomized regardless of cervical length and had no previous history of preterm birth or known Mullerian anomalies. The primary outcome was spontaneous preterm birth rate before 37 weeks. The secondary outcome was; spontaneous preterm birth before 34, 32, 28 weeks and neonatal outcome.

RESULTS

A total of 203 women were randomized to both groups, final analysis included 199 women as 4 were lost to follow up. The base line characteristics as well as gestational age at delivery were not significantly different between the study and the placebo group (34.7 ± 3.6 vs 34.5 ± 4.5, P = 0.626). Progesterone administration was not associated with a significant decrease in the spontaneous preterm birth rates before 37 weeks (73.5% vs 68%, P = 0.551), before 34 (20.6% vs 21.6%, P = 0.649), before 32 (8.8% vs 12.4%, P = 0.46) & before 28 (4.9% vs 3.1%, P = 0.555) weeks.

CONCLUSIONS

Rectal natural progesterone starting from the first trimester in IVF/ICSI twin pregnancies did not reduce spontaneous preterm birth.

TRIAL REGISTRATION

The trial was registered on 31 January 2014 at www.ISRCTN.com, number 69810120.

Authors+Show Affiliations

The Egyptian IVF center Maadi, 3, St. No. 161-Hadayek El-Maadi, 11431, Cairo, Egypt. Monaaboulghar71@gmail.com. Department of obstetrics and Gynecology, Cairo University, Cairo, Egypt. Monaaboulghar71@gmail.com. Cairo Fetal Medicine Unit, Cairo University, Cairo, Egypt. Monaaboulghar71@gmail.com.The Egyptian IVF center Maadi, 3, St. No. 161-Hadayek El-Maadi, 11431, Cairo, Egypt. Department of obstetrics and Gynecology, Cairo University, Cairo, Egypt.Department of obstetrics and Gynecology, Cairo University, Cairo, Egypt.The Egyptian IVF center Maadi, 3, St. No. 161-Hadayek El-Maadi, 11431, Cairo, Egypt.The Egyptian IVF center Maadi, 3, St. No. 161-Hadayek El-Maadi, 11431, Cairo, Egypt. Department of Obstetrics and Gynecology, Al Azhar University, Cairo, Egypt.The Egyptian IVF center Maadi, 3, St. No. 161-Hadayek El-Maadi, 11431, Cairo, Egypt. Department of obstetrics and Gynecology, Cairo University, Cairo, Egypt.The Egyptian IVF center Maadi, 3, St. No. 161-Hadayek El-Maadi, 11431, Cairo, Egypt. Department of obstetrics and Gynecology, Cairo University, Cairo, Egypt.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32517660

Citation

Aboulghar, Mona Mohamed, et al. "The Effect of Early Administration of Rectal Progesterone in IVF/ICSI Twin Pregnancies On the Preterm Birth Rate: a Randomized Trial." BMC Pregnancy and Childbirth, vol. 20, no. 1, 2020, p. 351.
Aboulghar MM, El-Faissal Y, Kamel A, et al. The effect of early administration of rectal progesterone in IVF/ICSI twin pregnancies on the preterm birth rate: a randomized trial. BMC Pregnancy Childbirth. 2020;20(1):351.
Aboulghar, M. M., El-Faissal, Y., Kamel, A., Mansour, R., Serour, G., Aboulghar, M., & Islam, Y. (2020). The effect of early administration of rectal progesterone in IVF/ICSI twin pregnancies on the preterm birth rate: a randomized trial. BMC Pregnancy and Childbirth, 20(1), 351. https://doi.org/10.1186/s12884-020-03033-4
Aboulghar MM, et al. The Effect of Early Administration of Rectal Progesterone in IVF/ICSI Twin Pregnancies On the Preterm Birth Rate: a Randomized Trial. BMC Pregnancy Childbirth. 2020 Jun 9;20(1):351. PubMed PMID: 32517660.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The effect of early administration of rectal progesterone in IVF/ICSI twin pregnancies on the preterm birth rate: a randomized trial. AU - Aboulghar,Mona Mohamed, AU - El-Faissal,Yahia, AU - Kamel,Ahmed, AU - Mansour,Ragaa, AU - Serour,Gamal, AU - Aboulghar,Mohamed, AU - Islam,Yomna, Y1 - 2020/06/09/ PY - 2019/07/26/received PY - 2020/05/25/accepted PY - 2020/6/11/entrez PY - 2020/6/11/pubmed PY - 2020/6/11/medline KW - And randomized placebo controlled double blind study KW - First trimester scan KW - IVF/ICSI KW - Preterm birth KW - Rectal progesterone KW - Twins SP - 351 EP - 351 JF - BMC pregnancy and childbirth JO - BMC Pregnancy Childbirth VL - 20 IS - 1 N2 - BACKGROUND: The rate of multiple pregnancies in IVF/ICSI ranges from 20 to 30%. The incidence of preterm birth in multiple pregnancies is as high as 60% and is even higher in pregnancies conceived after IVF & ICSI. The effect of progesterone on prevention of preterm birth in twins is controversial. Our group has proven a positive effect in reduction of preterm birth, by starting progesterone from the mid-trimester, in exclusively IVF/ICSI singleton pregnancies but not twins. The purpose of our current study was to explore the effect of earlier administration of natural progesterone, in IVF/ICSI twin pregnancies starting at 11-14 weeks for prevention of preterm birth. METHODS: This is a double-blind, placebo controlled, single center, randomized clinical trial. Women with dichorionic twin gestations, having an IVF/ICSI trial were randomized to receive natural rectal progesterone (800 mg daily) vs placebo, starting early from 11 to 14 weeks. They also received oral and vaginal antimicrobial agents as part of our routine treatment for vaginitis and urinary tract infection. They were randomized regardless of cervical length and had no previous history of preterm birth or known Mullerian anomalies. The primary outcome was spontaneous preterm birth rate before 37 weeks. The secondary outcome was; spontaneous preterm birth before 34, 32, 28 weeks and neonatal outcome. RESULTS: A total of 203 women were randomized to both groups, final analysis included 199 women as 4 were lost to follow up. The base line characteristics as well as gestational age at delivery were not significantly different between the study and the placebo group (34.7 ± 3.6 vs 34.5 ± 4.5, P = 0.626). Progesterone administration was not associated with a significant decrease in the spontaneous preterm birth rates before 37 weeks (73.5% vs 68%, P = 0.551), before 34 (20.6% vs 21.6%, P = 0.649), before 32 (8.8% vs 12.4%, P = 0.46) & before 28 (4.9% vs 3.1%, P = 0.555) weeks. CONCLUSIONS: Rectal natural progesterone starting from the first trimester in IVF/ICSI twin pregnancies did not reduce spontaneous preterm birth. TRIAL REGISTRATION: The trial was registered on 31 January 2014 at www.ISRCTN.com, number 69810120. SN - 1471-2393 UR - https://www.unboundmedicine.com/medline/citation/32517660/The_effect_of_early_administration_of_rectal_progesterone_in_IVF/ICSI_twin_pregnancies_on_the_preterm_birth_rate:_a_randomized_trial L2 - https://bmcpregnancychildbirth.biomedcentral.com/articles/10.1186/s12884-020-03033-4 DB - PRIME DP - Unbound Medicine ER -
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